81_FR_52597 81 FR 52445 - Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection

81 FR 52445 - Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 152 (August 8, 2016)

Page Range52445-52449
FR Document2016-18672

The Food and Drug Administration (FDA) is announcing the completion of the target of the goal established to address the Center for Devices and Radiological Health's (CDRH) 2014-2015 Strategic Priority ``Strike the Right Balance Between Premarket and Postmarket Data Collection.'' To achieve this Strategic Priority, CDRH established a goal to assure the appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance. We established a target date of December 31, 2015, by which to review 100 percent of product codes subject to a premarket approval application (PMA) that are legally marketed and were approved prior to 2010 to determine, for each such product code, whether or not, based on our current understanding of the technology, to reduce premarket data collection by relying more on postmarket controls, and whether to shift some premarket data collection to the postmarket setting or to pursue down-classification.

Federal Register, Volume 81 Issue 152 (Monday, August 8, 2016) 
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52445-52449]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1805]


Retrospective Review of Premarket Approval Application Devices; 
Striking the Balance Between Premarket and Postmarket Data Collection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
completion of the target of the goal established to address the Center 
for Devices and Radiological Health's (CDRH) 2014-2015 Strategic 
Priority ``Strike the Right Balance Between Premarket and Postmarket 
Data Collection.'' To achieve this Strategic Priority, CDRH established 
a goal to assure the appropriate balance between premarket and 
postmarket data

[[Page 52446]]

collection to facilitate and expedite the development and review of 
medical devices, in particular high-risk devices of public health 
importance. We established a target date of December 31, 2015, by which 
to review 100 percent of product codes subject to a premarket approval 
application (PMA) that are legally marketed and were approved prior to 
2010 to determine, for each such product code, whether or not, based on 
our current understanding of the technology, to reduce premarket data 
collection by relying more on postmarket controls, and whether to shift 
some premarket data collection to the postmarket setting or to pursue 
down-classification.

DATES: Submit either electronic or written comments by October 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-1805 for ``Retrospective Review of Premarket Approval 
Application Devices; Striking the Balance Between Premarket and 
Postmarket Data Collection.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-796-5676.

SUPPLEMENTARY INFORMATION:

I. Background

    One of three Strategic Priorities for 2014-2015 in CDRH is to 
``Strike the Right Balance Between Premarket and Postmarket Data 
Collection'' (Ref. 1).\1\ CDRH's vision is for patients in the United 
States to have first-in-the-world access to high-quality, safe, and 
effective medical devices of public health importance. A key 
determinant of early U.S. patient access to high-quality, safe, and 
effective devices is the extent of premarket data that device 
developers provide to FDA. Once a device developer decides to seek U.S. 
marketing approval or clearance, the extent of data that are collected 
premarket has an impact upon the length of time needed to complete a 
premarket submission--the more data to be collected premarket, the 
longer it may take to acquire the data and make the submission. 
Consequently, such data collection issues affect when U.S. patients 
have access to a medical device. On the other hand, it is also 
important that there are sufficient data to demonstrate a reasonable 
assurance of safety and effectiveness before a device that is subject 
to a premarket approval application (PMA) is approved for marketing in 
the United States. For this reason, it is important that CDRH strike 
the right balance between premarket and postmarket data collection. If 
CDRH can shift, when appropriate, some premarket data collection to the 
postmarket setting, CDRH could improve patient access to high-quality, 
safe, and effective medical devices of public health importance. 
However, patient safety could be undermined if, after determining that 
certain data could appropriately be shifted from the premarket to the 
postmarket setting, CDRH shifted that data collection to the postmarket 
setting without adequate assurances that necessary and timely 
postmarket data collection will occur. For this reason, CDRH strives to 
balance the premarket data and postmarket collection, in accordance 
with section 513(a)(3)(C) (21 U.S.C. 360c(a)(3)(C)) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), which directs CDRH to 
consider whether the extent of data that otherwise would be required 
for

[[Page 52447]]

approval of a PMA with respect to effectiveness can be reduced through 
reliance on postmarket controls.
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    \1\ CDRH's 2014-2015 Strategic Priorities include ``Strengthen 
the Clinical Trial Enterprise'' and ``Provide Excellent Customer 
Service'' in addition to ``Strike the Right Balance Between 
Premarket and Postmarket Data Collection'' (Ref. 1).
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    In order to achieve the proper balance between premarket and 
postmarket data collection, CDRH resolved in its Strategic Priorities 
for 2014-2015 to take several actions. CDRH committed to developing and 
seeking public comment on a framework for when it would be appropriate 
to shift premarket data collection to the postmarket setting. Pursuant 
to this commitment, CDRH and the Center for Biologics Evaluation and 
Research (CBER) issued the guidance, ``Balancing Premarket and 
Postmarket Data Collection for Devices Subject to Premarket Approval,'' 
on April 13, 2015 (80 FR 19672), which provided FDA's policy of 
balancing premarket and postmarket data collection during the Agency's 
review of PMAs (Ref. 2). This guidance outlines how FDA would consider 
the role of postmarket information in determining the appropriate type 
and amount of data that should be collected in the premarket setting to 
support premarket approval, while still meeting the statutory standard 
of a reasonable assurance of safety and effectiveness. Furthermore, 
under existing authorities, CDRH and CBER issued a guidance document on 
April 13, 2015 (80 FR 19669), entitled ``Expedited Access for Premarket 
Approval Medical Devices Intended for Unmet Medical Need for Life 
Threatening or Irreversibly Debilitating Diseases or Conditions'' (Ref. 
3). This guidance describes FDA's voluntary expedited access PMA 
program for certain medical devices to facilitate patient access to 
these devices by expediting the development, assessment, and review of 
certain devices that demonstrate the potential to address unmet medical 
needs for life threatening or irreversibly debilitating diseases or 
conditions. To expedite access for devices addressing unmet needs, this 
pathway to market shifts appropriate components of premarket data 
collection to the postmarket setting, while maintaining the statutory 
standard of a reasonable assurance of safety and effectiveness. In 
addition, CDRH has developed a mechanism to assure prospectively the 
appropriate balance of premarket and postmarket data collection for new 
devices subject to a PMA. Specifically, when CDRH issues a final 
decision for an original PMA or panel-track supplement to a PMA, CDRH 
conducts a prospective assessment to determine if the device type is a 
candidate for shifting some premarket data collection to the 
postmarket, reducing premarket data collection through reliance on 
postmarket controls or reclassification.
    Another action in pursuit of the goal to strike the right balance 
between premarket and postmarket data collection was to commit to 
conducting a retrospective review of all PMA product codes (procodes) 
with active PMAs approved prior to 2010 to determine whether data 
typically collected premarket could be shifted to the postmarket 
setting, and whether premarket data collection could be reduced through 
reliance on postmarket controls or devices could be reclassified (down-
classified) in light of our current understanding of the technology 
(Ref. 1). In general, some premarket data collections for class III 
devices that are currently marketed may be reduced through reliance on 
postmarket controls or shifted to the postmarket setting if warranted, 
based on CDRH's review experience as well as the postmarket performance 
and the current body of evidence regarding the benefit-risk profile of 
these devices. CDRH currently receives PMA submissions on the majority 
of these class III devices, and a change in premarket data collection 
is expected to expedite the approval of future PMA submissions. CDRH 
has periodically taken such actions consistent with the medical device 
statutory framework but has typically done so on an ad hoc basis. On 
the other hand, when FDA determines that it is necessary to provide 
reasonable assurance that a device is safe and effective, CDRH may 
require more data based on our current understanding of that type of 
technology or based on an issue raised by the data submitted by a 
sponsor for their device. CDRH will also up-classify a device, if 
warranted, based on the current state of the science. For example, on 
January 5, 2016, CDRH issued a final order up-classifying surgical mesh 
when intended for use for pelvic organ prolapse (81 FR 354), and on 
June 2, 2014, CDRH issued a final order up-classifying sunlamps and 
sunlamp products (tanning beds/booths) (79 FR 31205). However, up-
classification is not warranted for the devices subject to this 
retrospective review, because they are already in the highest risk 
classification.
    During this retrospective review, devices were analyzed according 
to procodes. CDRH targeted the date of December 31, 2014, by which to 
review 50 percent of the procodes for devices that are subject to a PMA 
and are legally marketed to determine whether or not to change 
premarket data collection by shifting the data collection to the 
postmarket setting, reducing premarket data collection through reliance 
on postmarket controls, or pursuing reclassification (Ref. 1). This 
target extended to have 75 percent completed by June 30, 2015, and 100 
percent completed by December 31, 2015.
    On April 29, 2015, CDRH announced its progress on this priority and 
solicited comments on the procodes that were identified as candidates 
for reclassification, a reduction in premarket data collection through 
reliance on postmarket controls, or a shift in premarket data 
collection to postmarket for those procodes reviewed through December 
31, 2014 (80 FR 23798). FDA received 11 sets of comments, which 
generally supported FDA's retrospective review effort and provided 
input on specific procodes that were identified as candidates for 
reclassification or were determined to remain class III with no changes 
in data collection. FDA will consider these comments when making final 
determinations on the reclassification of these procodes.
    During 2015, FDA reviewed the remaining procodes that were 
identified for the retrospective review. While completing the 
retrospective review, FDA found that the LMX procode was included in 
the retrospective review in error, because the jaundice meter device 
type is covered by a different procode, not within the scope of the 
retrospective review. The jaundice meter device type is classified 
under 21 CFR 862.1113 and assigned the procode MQM, and accordingly, 
this device type requires a 510(k) premarket notification. Therefore, 
the procode LMX has been excluded from the analysis.
    The purpose of this Federal Register notice is to solicit comments 
on the remaining procodes that have been identified as candidates for 
reclassification, a reduction in premarket data collection through 
reliance on postmarket controls, or a shift in premarket data 
collection to postmarket for those procodes reviewed through December 
31, 2015. Efforts to reclassify and to communicate changes to data 
collections with stakeholders will be prioritized based on both the 
public health impact and Center resources.

II. Achievement of Goal Targets

    Retrospective analysis of the class III medical device procodes was 
intended to determine if current classifications and data collections 
remain appropriate for determining a reasonable assurance of safety and 
effectiveness. As our understanding of the technology associated with 
individual medical devices has increased and we have a better 
understanding of the risks

[[Page 52448]]

associated with the technology of each device, our understanding of the 
type and amount of data that are needed to demonstrate a reasonable 
assurance of safety and effectiveness also evolves. We use this 
evolution in our understanding to require the least burdensome amount 
of data necessary to evaluate device effectiveness, following the least 
burdensome provisions of the FD&C Act (section 513(a)(3)(D)(ii)). Under 
section 513 of the FD&C Act, a device is a class III device and 
requires premarket approval if general controls and special controls 
are insufficient to provide reasonable assurance of the safety and 
effectiveness of the device, and if the device is to be used for 
supporting or sustaining human life or of substantial importance in 
preventing impairment of human health or if the device presents a 
potential unreasonable risk of illness or injury. In order to 
reclassify a class III device into class II, the device must meet the 
statutory criteria for class II: A device that cannot be classified as 
a class I device, because general controls are insufficient to provide 
reasonable assurance of the safety and effectiveness of the device, and 
for which there is sufficient information to establish special controls 
to provide such assurance. As new information becomes available over 
time, the accumulated information available for a device may be 
sufficient to establish special controls to provide a reasonable 
assurance of safety and effectiveness; therefore, the classification of 
the device may be changed either up or down.
    In February 2014, CDRH began its retrospective review with procodes 
associated with active PMAs approved prior to 2010. PMA procodes 
created since 2010 were not included in this retrospective review 
because these recently created procodes do not yet have sufficient new 
information for a change in FDA's current understanding of the device's 
postmarket performance profile. As of December 31, 2015, CDRH reviewed 
all procodes included in this retrospective review, meeting its 100 
percent review target.
    The results of this analysis include recommendations for procodes 
that are candidates for reclassification, a reduction in premarket data 
collection through reliance on postmarket controls, or a shift in 
premarket data collection to postmarket collection. These results are 
published online, along with the results of the first cohort of 
procodes at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm 
(Ref. 4). The results of this second cohort of procodes reviewed for 
this analysis are additive to those previously reported. CDRH is 
continuing to consider the comments received on the first cohort of 
procodes reported in April 2015, and efforts to reclassify and to 
communicate changes to data collections with stakeholders are being 
prioritized based on both the public health impact and Center 
resources. The following paragraph describes the organization of the 
results into tables, which are available for public review online (Ref. 
4).
    As discussed in further detail below, for the purposes of this 
retrospective review, we evaluated each procode on a balance of factors 
to determine the current benefit-risk profile and if our review 
indicates special controls could be established to provide a reasonable 
assurance of safety and effectiveness. If so, the corresponding procode 
was listed in the category ``Candidates for Reclassification to Class 
II'' (table 1). If it was determined that special controls would not be 
sufficient to provide reasonable assurance of the safety and 
effectiveness of the device, then the procode was evaluated to 
determine if some premarket data collection for PMA submission could be 
shifted to postmarket collection, or if premarket data collection could 
be reduced through reliance on postmarket controls. If it was 
determined that a change of data collection could continue to provide 
reasonable assurance of the safety and effectiveness of the device, 
then the procode was listed in the category ``Candidates for reduction 
of data collection through reliance on postmarket controls or shift of 
data collection from premarket to postmarket'' (table 2). This category 
includes procodes for which premarket data collection could be shifted 
to postmarket data collection, premarket data collection could be 
decreased through reliance on postmarket controls, or postmarket data 
could no longer be needed. Finally, table 3 includes procodes for which 
a reduction in data collection through reliance on postmarket controls 
or shift in data collection from premarket to postmarket and/or 
reclassification occurred in 2015 during FDA's retrospective review of 
PMAs.
    In this retrospective review, postmarket performance data, 
technology and performance considerations, and other relevant 
considerations were evaluated for each procode. These factors were used 
to evaluate the current benefit-risk profile to determine if the 
devices are good candidates for a reduction in premarket data 
collection through reliance on postmarket controls, a shift of 
premarket data collection to postmarket, or reclassification. 
Postmarket performance data (including recent PMA Annual Reports, 
literature reviews, total product lifecycle reports, medical device 
reporting analysis, market penetration, and recall analysis) were 
investigated for any performance concerns or problems that outpace any 
increases in device use or acceptance. In evaluating the technology and 
performance considerations for the procodes, performance concerns or 
problems that were uncovered in the review of postmarket data were 
considered unfavorable factors for a change in data collection or 
reclassification. Favorable factors to indicate that a device is a good 
candidate for a change in data collection or reclassification included: 
Whether risks are now well understood and are determined to be moderate 
to low; technology uncertainties have been alleviated; performance 
standards or non-clinical tests have been developed that could be 
surrogates for some clinical testing; the need for a controlled study 
could be eliminated due to defined objective performance criteria; the 
device has been shown to have good short-term performance; or concerns 
are limited to long-term performance or rare adverse events.
    Finally, several relevant considerations were evaluated for each 
procode. Unfavorable factors for devices to be considered candidates 
for a change in data collection or reclassification included: Whether 
there have been significant changes implemented to address safety or 
effectiveness since the devices have been on the market; whether the 
review of annual reports and manufacturing changes has been important 
to maintain safety of the devices; whether there were a limited number 
of approvals or limited clinical use of the devices, due to inadequate 
data needed to conduct this scientific assessment.
    After completion of this retrospective review, FDA will prioritize 
the procodes identified as candidates for reclassification (table 1, 
Ref. 4) according to public health impact and Center resources, in 
order to determine the top priority procodes for which reclassification 
would have the greatest impact. The procodes identified as top priority 
candidates for reclassification will proceed through the 
reclassification procedures according to 21 CFR part 860. FDA will also 
prioritize the procodes identified as candidates for a change in data 
collection (table 2, Ref. 4) according to public health impact and 
Center resources, in order to determine which reductions of or shifts 
to data collection would have the greatest

[[Page 52449]]

impact. FDA encourages firms to submit a presubmission to get feedback 
on their data collection plan or contact the appropriate review branch 
for additional information if they are in the process of developing a 
device in one of these categories.

III. Paperwork Reduction Act of 1995

    This document refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the 
date this document publishes in the Federal Register, but Web sites are 
subject to change over time.

1. FDA, ``CDRH 2014-2015 Strategic Priorities,'' 2014, http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM384576.pdf.
2. ``Guidance for Industry and FDA Staff: Balancing Premarket and 
Postmarket Data Collection for Devices Subject to Premarket 
Approval,'' April 2015, http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393994.pdf.
3. ``Guidance for Industry and FDA Staff: Expedited Access for 
Premarket Approval and De Novo Medical Devices Intended for Unmet 
Medical Need for Life Threatening or Irreversibly Debilitating 
Diseases or Conditions,'' April 2015, http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393978.pdf.
4. ``Second and final cohort of Results of the 2014-2015 Strategic 
Priority: Strike the Right Balance between Premarket and Postmarket 
Data Collection, '' available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm.


    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18672 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52445 written/paper submission and in the regulatoryinformation/dockets/ input, can be found in the Federal manner detailed (see ‘‘Written/Paper default.htm. Register document from the June 10, Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to 2106, public meeting (https:// read background documents or the www.federalregister.gov/articles/2016/ Written/Paper Submissions electronic and written/paper comments 05/11/2016-11098/over-the-counter- Submit written/paper submissions as received, go to http:// monograph-user-fees-public-meeting- follows: www.regulations.gov and insert the request-for-comments). The meeting • Mail/Hand delivery/Courier (for docket number, found in brackets in the transcript, meeting recording, and written/paper submissions): Division of heading of this document, into the presentations from the June 10, 2016, Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts public meeting, which can serve as and Drug Administration, 5630 Fishers and/or go to the Division of Dockets further background information, can be Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. found at: http://www.fda.gov/Drugs/ • For written/paper comments 1061, Rockville, MD 20852. NewsEvents/ucm499390.htm. submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: II. Stakeholder Meeting Participation Management, FDA will post your Amy Bertha, Office of Executive comment, as well as any attachments, Programs, Center for Drug Evaluation FDA is seeking participation at the except for information submitted, and Research, Food and Drug Webinar by stakeholders, including marked and identified, as confidential, Administration, 10903 New Hampshire scientific and academic experts, health if submitted as detailed in Ave., Silver Spring, MD 20993–0002, care professionals, representatives of ‘‘Instructions.’’ 301–796–1647, email: patient and consumer advocacy groups, and representatives of the OTC Instructions: All submissions received OTCMonographUserFeeProgram monograph industry. Participating in must include the Docket No. FDA– @fda.hhs.gov. the Webinar is free. The Webinar format 2016–N–1092 for ‘‘Over-the-Counter SUPPLEMENTARY INFORMATION: will include presentations by FDA staff Monograph User Fees: Reopening of and an opportunity for stakeholders to Comment Period; Stakeholder Meeting.’’ I. Background ask questions. If you wish to attend the Received comments will be placed in FDA is reopening until October 6, Webinar, FDA asks that you please the docket and, except for those 2016, the comment period for the register through Eventbrite by Tuesday, submitted as ‘‘Confidential document that announced a public August 30, 2016 (https:// Submissions,’’ publicly viewable at meeting in the Federal Register of May www.eventbrite.com/e/over-the-counter- http://www.regulations.gov or at the 11, 2016 (81 FR 29275). In the monograph-user-fees-stakeholder- Division of Dockets Management document, FDA invited public comment meeting-tickets-26751882601). FDA will between 9 a.m. and 4 p.m., Monday as the Agency considers a user-fee email the registered attendees a URL to through Friday. program for nonprescription (over-the- join the Webinar at least 1 day before • Confidential Submissions—To counter or OTC) monograph drugs. A the meeting. submit a comment with confidential user-fee program would provide funding Dated August 3, 2016. information that you do not wish to be to supplement congressional non-user- made publicly available, submit your fee appropriations, and would support Leslie Kux, comments only as a written/paper timely and efficient FDA review of the Associate Commissioner for Policy. submission. You should submit two efficacy and safety of ingredients [FR Doc. 2016–18717 Filed 8–5–16; 8:45 am] copies total. One copy will include the included in or proposed for inclusion in BILLING CODE 4164–01–P information you claim to be confidential a monograph. A public meeting on this with a heading or cover note that states topic was held on June 10, 2016, and ‘‘THIS DOCUMENT CONTAINS interested persons were given until July DEPARTMENT OF HEALTH AND CONFIDENTIAL INFORMATION.’’ The 11, 2016, to submit comments. To HUMAN SERVICES Agency will review this copy, including ensure that all interested persons have Food and Drug Administration the claimed confidential information, in sufficient opportunity to share their its consideration of comments. The views on a potential OTC monograph [Docket No. FDA–2015–N–1805] second copy, which will have the user-fee program, FDA is reopening the claimed confidential information comment period until October 6, 2016. Retrospective Review of Premarket redacted/blacked out, will be available FDA will hold a Webinar for Approval Application Devices; Striking for public viewing and posted on http:// stakeholders on September 6, 2016. This the Balance Between Premarket and www.regulations.gov. Submit both Webinar is intended to be a followup to Postmarket Data Collection copies to the Division of Dockets the June 10, 2016, public meeting and AGENCY: Food and Drug Administration, Management. If you do not wish your provide stakeholders with a status HHS. name and contact information to be update on the process of FDA and ACTION: Notice; request for comments. made publicly available, you can industry discussions that began in July provide this information on the cover 2016. Meeting minutes from these SUMMARY: The Food and Drug sheet and not in the body of your discussions can be found at: http:// Administration (FDA) is announcing the comments and you must identify this www.fda.gov/omuf. Additional completion of the target of the goal information as ‘‘confidential.’’ Any background information on OTC established to address the Center for information marked as ‘‘confidential’’ monograph drugs (such as how OTC Devices and Radiological Health’s mstockstill on DSK3G9T082PROD with NOTICES will not be disclosed except in drugs can be marketed, the differences (CDRH) 2014–2015 Strategic Priority accordance with 21 CFR 10.20 and other between marketing through approved ‘‘Strike the Right Balance Between applicable disclosure law. For more applications and marketing under the Premarket and Postmarket Data information about FDA’s posting of monographs), factors FDA considers Collection.’’ To achieve this Strategic comments to public dockets, see 80 FR important in developing a user-fee Priority, CDRH established a goal to 56469, September 18, 2015, or access program, and the questions FDA asked assure the appropriate balance between the information at: http://www.fda.gov/ the public to consider and provide premarket and postmarket data VerDate Sep<11>2014 22:23 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1

52446 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices collection to facilitate and expedite the marked and identified, as confidential, Administration, 10903 New Hampshire development and review of medical if submitted as detailed in Ave., Bldg. 66, Rm. 5454, Silver Spring, devices, in particular high-risk devices ‘‘Instructions.’’ MD 20993–0002, 301–796–5676. of public health importance. We Instructions: All submissions received SUPPLEMENTARY INFORMATION: established a target date of December 31, must include the Docket No. FDA– 2015, by which to review 100 percent of 2015–N–1805 for ‘‘Retrospective Review I. Background product codes subject to a premarket of Premarket Approval Application One of three Strategic Priorities for approval application (PMA) that are Devices; Striking the Balance Between 2014–2015 in CDRH is to ‘‘Strike the legally marketed and were approved Premarket and Postmarket Data Right Balance Between Premarket and prior to 2010 to determine, for each Collection.’’ Received comments will be Postmarket Data Collection’’ (Ref. 1).1 such product code, whether or not, placed in the docket and, except for CDRH’s vision is for patients in the based on our current understanding of those submitted as ‘‘Confidential United States to have first-in-the-world the technology, to reduce premarket Submissions,’’ publicly viewable at access to high-quality, safe, and data collection by relying more on http://www.regulations.gov or at the effective medical devices of public postmarket controls, and whether to Division of Dockets Management health importance. A key determinant of shift some premarket data collection to between 9 a.m. and 4 p.m., Monday early U.S. patient access to high-quality, the postmarket setting or to pursue through Friday. safe, and effective devices is the extent down-classification. • Confidential Submissions—To of premarket data that device developers DATES: Submit either electronic or submit a comment with confidential provide to FDA. Once a device written comments by October 7, 2016. information that you do not wish to be developer decides to seek U.S. ADDRESSES: You may submit comments made publicly available, submit your marketing approval or clearance, the as follows: comments only as a written/paper extent of data that are collected submission. You should submit two premarket has an impact upon the Electronic Submissions copies total. One copy will include the length of time needed to complete a Submit electronic comments in the information you claim to be confidential premarket submission—the more data to following way: with a heading or cover note that states be collected premarket, the longer it • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS may take to acquire the data and make www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The the submission. Consequently, such instructions for submitting comments. Agency will review this copy, including data collection issues affect when U.S. Comments submitted electronically, the claimed confidential information, in patients have access to a medical including attachments, to http:// its consideration of comments. The device. On the other hand, it is also www.regulations.gov will be posted to second copy, which will have the important that there are sufficient data the docket unchanged. Because your claimed confidential information to demonstrate a reasonable assurance comment will be made public, you are redacted/blacked out, will be available of safety and effectiveness before a solely responsible for ensuring that your for public viewing and posted on http:// device that is subject to a premarket comment does not include any www.regulations.gov. Submit both approval application (PMA) is approved confidential information that you or a copies to the Division of Dockets for marketing in the United States. For third party may not wish to be posted, Management. If you do not wish your this reason, it is important that CDRH such as medical information, your or name and contact information to be strike the right balance between anyone else’s Social Security number, or made publicly available, you can premarket and postmarket data confidential business information, such provide this information on the cover collection. If CDRH can shift, when as a manufacturing process. Please note sheet and not in the body of your appropriate, some premarket data that if you include your name, contact comments and you must identify this collection to the postmarket setting, information, or other information that information as ‘‘confidential.’’ Any CDRH could improve patient access to identifies you in the body of your information marked as ‘‘confidential’’ high-quality, safe, and effective medical comments, that information will be will not be disclosed except in devices of public health importance. posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other However, patient safety could be • If you want to submit a comment applicable disclosure law. For more undermined if, after determining that with confidential information that you information about FDA’s posting of certain data could appropriately be do not wish to be made available to the comments to public dockets, see 80 FR shifted from the premarket to the public, submit the comment as a 56469, September 18, 2015, or access postmarket setting, CDRH shifted that written/paper submission and in the the information at: http://www.fda.gov/ data collection to the postmarket setting manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ without adequate assurances that Submissions’’ and ‘‘Instructions’’). default.htm. necessary and timely postmarket data Docket: For access to the docket to collection will occur. For this reason, Written/Paper Submissions read background documents or the CDRH strives to balance the premarket Submit written/paper submissions as electronic and written/paper comments data and postmarket collection, in follows: received, go to http:// accordance with section 513(a)(3)(C) (21 • Mail/Hand delivery/Courier (for www.regulations.gov and insert the U.S.C. 360c(a)(3)(C)) of the Federal written/paper submissions): Division of docket number, found in brackets in the Food, Drug, and Cosmetic Act (the Dockets Management (HFA–305), Food heading of this document, into the FD&C Act), which directs CDRH to mstockstill on DSK3G9T082PROD with NOTICES and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts consider whether the extent of data that Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets otherwise would be required for • For written/paper comments Management, 5630 Fishers Lane, Rm. submitted to the Division of Dockets 1061, Rockville, MD 20852. 1 CDRH’s 2014–2015 Strategic Priorities include ‘‘Strengthen the Clinical Trial Enterprise’’ and Management, FDA will post your FOR FURTHER INFORMATION CONTACT: ‘‘Provide Excellent Customer Service’’ in addition comment, as well as any attachments, Nancy Braier, Center for Devices and to ‘‘Strike the Right Balance Between Premarket and except for information submitted, Radiological Health, Food and Drug Postmarket Data Collection’’ (Ref. 1). 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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52447 approval of a PMA with respect to collection through reliance on postmarket controls, or pursuing effectiveness can be reduced through postmarket controls or reclassification. reclassification (Ref. 1). This target reliance on postmarket controls. Another action in pursuit of the goal extended to have 75 percent completed In order to achieve the proper balance to strike the right balance between by June 30, 2015, and 100 percent between premarket and postmarket data premarket and postmarket data completed by December 31, 2015. collection, CDRH resolved in its collection was to commit to conducting On April 29, 2015, CDRH announced Strategic Priorities for 2014–2015 to take a retrospective review of all PMA its progress on this priority and solicited several actions. CDRH committed to product codes (procodes) with active comments on the procodes that were developing and seeking public comment PMAs approved prior to 2010 to identified as candidates for on a framework for when it would be determine whether data typically reclassification, a reduction in appropriate to shift premarket data collected premarket could be shifted to premarket data collection through collection to the postmarket setting. the postmarket setting, and whether reliance on postmarket controls, or a Pursuant to this commitment, CDRH premarket data collection could be shift in premarket data collection to and the Center for Biologics Evaluation reduced through reliance on postmarket postmarket for those procodes reviewed and Research (CBER) issued the controls or devices could be reclassified through December 31, 2014 (80 FR guidance, ‘‘Balancing Premarket and (down-classified) in light of our current 23798). FDA received 11 sets of Postmarket Data Collection for Devices understanding of the technology (Ref. comments, which generally supported Subject to Premarket Approval,’’ on 1). In general, some premarket data FDA’s retrospective review effort and collections for class III devices that are provided input on specific procodes April 13, 2015 (80 FR 19672), which currently marketed may be reduced that were identified as candidates for provided FDA’s policy of balancing through reliance on postmarket controls reclassification or were determined to premarket and postmarket data or shifted to the postmarket setting if remain class III with no changes in data collection during the Agency’s review of warranted, based on CDRH’s review collection. FDA will consider these PMAs (Ref. 2). This guidance outlines experience as well as the postmarket comments when making final how FDA would consider the role of performance and the current body of determinations on the reclassification of postmarket information in determining evidence regarding the benefit-risk these procodes. the appropriate type and amount of data During 2015, FDA reviewed the profile of these devices. CDRH currently that should be collected in the remaining procodes that were identified receives PMA submissions on the premarket setting to support premarket majority of these class III devices, and for the retrospective review. While approval, while still meeting the a change in premarket data collection is completing the retrospective review, statutory standard of a reasonable expected to expedite the approval of FDA found that the LMX procode was assurance of safety and effectiveness. future PMA submissions. CDRH has included in the retrospective review in Furthermore, under existing authorities, periodically taken such actions error, because the jaundice meter device CDRH and CBER issued a guidance consistent with the medical device type is covered by a different procode, document on April 13, 2015 (80 FR statutory framework but has typically not within the scope of the retrospective 19669), entitled ‘‘Expedited Access for done so on an ad hoc basis. On the other review. The jaundice meter device type Premarket Approval Medical Devices hand, when FDA determines that it is is classified under 21 CFR 862.1113 and Intended for Unmet Medical Need for necessary to provide reasonable assigned the procode MQM, and Life Threatening or Irreversibly assurance that a device is safe and accordingly, this device type requires a Debilitating Diseases or Conditions’’ effective, CDRH may require more data 510(k) premarket notification. (Ref. 3). This guidance describes FDA’s based on our current understanding of Therefore, the procode LMX has been voluntary expedited access PMA that type of technology or based on an excluded from the analysis. program for certain medical devices to issue raised by the data submitted by a The purpose of this Federal Register facilitate patient access to these devices sponsor for their device. CDRH will also notice is to solicit comments on the by expediting the development, up-classify a device, if warranted, based remaining procodes that have been assessment, and review of certain on the current state of the science. For identified as candidates for devices that demonstrate the potential example, on January 5, 2016, CDRH reclassification, a reduction in to address unmet medical needs for life issued a final order up-classifying premarket data collection through threatening or irreversibly debilitating surgical mesh when intended for use for reliance on postmarket controls, or a diseases or conditions. To expedite pelvic organ prolapse (81 FR 354), and shift in premarket data collection to access for devices addressing unmet on June 2, 2014, CDRH issued a final postmarket for those procodes reviewed needs, this pathway to market shifts order up-classifying sunlamps and through December 31, 2015. Efforts to appropriate components of premarket sunlamp products (tanning beds/booths) reclassify and to communicate changes data collection to the postmarket setting, (79 FR 31205). However, up- to data collections with stakeholders while maintaining the statutory classification is not warranted for the will be prioritized based on both the standard of a reasonable assurance of devices subject to this retrospective public health impact and Center safety and effectiveness. In addition, review, because they are already in the resources. CDRH has developed a mechanism to highest risk classification. assure prospectively the appropriate During this retrospective review, II. Achievement of Goal Targets balance of premarket and postmarket devices were analyzed according to Retrospective analysis of the class III data collection for new devices subject procodes. CDRH targeted the date of medical device procodes was intended to a PMA. Specifically, when CDRH December 31, 2014, by which to review to determine if current classifications mstockstill on DSK3G9T082PROD with NOTICES issues a final decision for an original 50 percent of the procodes for devices and data collections remain appropriate PMA or panel-track supplement to a that are subject to a PMA and are legally for determining a reasonable assurance PMA, CDRH conducts a prospective marketed to determine whether or not to of safety and effectiveness. As our assessment to determine if the device change premarket data collection by understanding of the technology type is a candidate for shifting some shifting the data collection to the associated with individual medical premarket data collection to the postmarket setting, reducing premarket devices has increased and we have a postmarket, reducing premarket data data collection through reliance on better understanding of the risks VerDate Sep<11>2014 22:23 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1

52448 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices associated with the technology of each this analysis are additive to those data collection to postmarket, or device, our understanding of the type previously reported. CDRH is reclassification. Postmarket performance and amount of data that are needed to continuing to consider the comments data (including recent PMA Annual demonstrate a reasonable assurance of received on the first cohort of procodes Reports, literature reviews, total product safety and effectiveness also evolves. reported in April 2015, and efforts to lifecycle reports, medical device We use this evolution in our reclassify and to communicate changes reporting analysis, market penetration, understanding to require the least to data collections with stakeholders are and recall analysis) were investigated burdensome amount of data necessary being prioritized based on both the for any performance concerns or to evaluate device effectiveness, public health impact and Center problems that outpace any increases in following the least burdensome resources. The following paragraph device use or acceptance. In evaluating provisions of the FD&C Act (section describes the organization of the results the technology and performance 513(a)(3)(D)(ii)). Under section 513 of into tables, which are available for considerations for the procodes, the FD&C Act, a device is a class III public review online (Ref. 4). performance concerns or problems that device and requires premarket approval As discussed in further detail below, were uncovered in the review of if general controls and special controls for the purposes of this retrospective postmarket data were considered are insufficient to provide reasonable review, we evaluated each procode on a unfavorable factors for a change in data assurance of the safety and effectiveness balance of factors to determine the collection or reclassification. Favorable of the device, and if the device is to be current benefit-risk profile and if our factors to indicate that a device is a good used for supporting or sustaining review indicates special controls could candidate for a change in data collection human life or of substantial importance be established to provide a reasonable or reclassification included: Whether in preventing impairment of human assurance of safety and effectiveness. If risks are now well understood and are health or if the device presents a so, the corresponding procode was determined to be moderate to low; potential unreasonable risk of illness or listed in the category ‘‘Candidates for technology uncertainties have been injury. In order to reclassify a class III Reclassification to Class II’’ (table 1). If alleviated; performance standards or device into class II, the device must it was determined that special controls non-clinical tests have been developed meet the statutory criteria for class II: A would not be sufficient to provide that could be surrogates for some device that cannot be classified as a reasonable assurance of the safety and clinical testing; the need for a controlled class I device, because general controls effectiveness of the device, then the study could be eliminated due to are insufficient to provide reasonable procode was evaluated to determine if defined objective performance criteria; assurance of the safety and effectiveness some premarket data collection for PMA the device has been shown to have good of the device, and for which there is submission could be shifted to short-term performance; or concerns are sufficient information to establish postmarket collection, or if premarket limited to long-term performance or rare special controls to provide such data collection could be reduced adverse events. assurance. As new information becomes through reliance on postmarket controls. Finally, several relevant available over time, the accumulated If it was determined that a change of considerations were evaluated for each information available for a device may data collection could continue to procode. Unfavorable factors for devices be sufficient to establish special controls provide reasonable assurance of the to be considered candidates for a change to provide a reasonable assurance of safety and effectiveness of the device, in data collection or reclassification safety and effectiveness; therefore, the then the procode was listed in the included: Whether there have been classification of the device may be category ‘‘Candidates for reduction of significant changes implemented to changed either up or down. data collection through reliance on address safety or effectiveness since the In February 2014, CDRH began its postmarket controls or shift of data devices have been on the market; retrospective review with procodes collection from premarket to whether the review of annual reports associated with active PMAs approved postmarket’’ (table 2). This category and manufacturing changes has been prior to 2010. PMA procodes created includes procodes for which premarket important to maintain safety of the since 2010 were not included in this data collection could be shifted to devices; whether there were a limited retrospective review because these postmarket data collection, premarket number of approvals or limited clinical recently created procodes do not yet data collection could be decreased use of the devices, due to inadequate have sufficient new information for a through reliance on postmarket controls, data needed to conduct this scientific change in FDA’s current understanding or postmarket data could no longer be assessment. of the device’s postmarket performance needed. Finally, table 3 includes After completion of this retrospective profile. As of December 31, 2015, CDRH procodes for which a reduction in data review, FDA will prioritize the procodes reviewed all procodes included in this collection through reliance on identified as candidates for retrospective review, meeting its 100 postmarket controls or shift in data reclassification (table 1, Ref. 4) percent review target. collection from premarket to postmarket according to public health impact and The results of this analysis include and/or reclassification occurred in 2015 Center resources, in order to determine recommendations for procodes that are during FDA’s retrospective review of the top priority procodes for which candidates for reclassification, a PMAs. reclassification would have the greatest reduction in premarket data collection In this retrospective review, impact. The procodes identified as top through reliance on postmarket controls, postmarket performance data, priority candidates for reclassification or a shift in premarket data collection to technology and performance will proceed through the reclassification postmarket collection. These results are considerations, and other relevant procedures according to 21 CFR part mstockstill on DSK3G9T082PROD with NOTICES published online, along with the results considerations were evaluated for each 860. FDA will also prioritize the of the first cohort of procodes at http:// procode. These factors were used to procodes identified as candidates for a www.fda.gov/AboutFDA/CentersOffices/ evaluate the current benefit-risk profile change in data collection (table 2, Ref. OfficeofMedicalProductsandTobacco/ to determine if the devices are good 4) according to public health impact and CDRH/CDRHVisionandMission/ candidates for a reduction in premarket Center resources, in order to determine default.htm (Ref. 4). The results of this data collection through reliance on which reductions of or shifts to data second cohort of procodes reviewed for postmarket controls, a shift of premarket collection would have the greatest VerDate Sep<11>2014 22:23 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1

Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52449 impact. FDA encourages firms to submit DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper a presubmission to get feedback on their HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). data collection plan or contact the Food and Drug Administration Written/Paper Submissions appropriate review branch for additional information if they are in the [Docket No. FDA–2016–D–2319] Submit written/paper submissions as process of developing a device in one of follows: these categories. Ulcerative Colitis: Clinical Trial • Mail/Hand delivery/Courier (for Endpoints; Draft Guidance for written/paper submissions): Division of III. Paperwork Reduction Act of 1995 Industry; Availability Dockets Management (HFA–305), Food This document refers to previously and Drug Administration, 5630 Fishers approved collections of information AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. found in FDA regulations. These HHS. • For written/paper comments collections of information are subject to ACTION: Notice of availability. submitted to the Division of Dockets review by the Office of Management and Management, FDA will post your Budget (OMB) under the Paperwork SUMMARY: The Food and Drug comment, as well as any attachments, Reduction Act of 1995 (44 U.S.C. 3501– Administration (FDA or Agency) is except for information submitted, 3520). The collections of information in announcing the availability of a draft marked and identified, as confidential, 21 CFR part 814 have been approved guidance for industry entitled if submitted as detailed in under OMB control number 0910–0231. ‘‘Ulcerative Colitis: Clinical Trial ‘‘Instructions.’’ Endpoints.’’ The purpose of this Instructions: All submissions received IV. References guidance is to assist sponsors in the must include the Docket No. FDA– The following references have been clinical development of drugs for the 2016–D–2319 for ‘‘Ulcerative Colitis: placed on display in the Division of treatment of ulcerative colitis (UC) in Clinical Trial Endpoints; Draft Guidance Dockets Management (see ADDRESSES) adult and pediatric patients. for Industry; Availability.’’ Received and are available for viewing by Specifically, this guidance addresses comments will be placed in the docket interested persons between 9 a.m. and 4 FDA’s current thinking regarding and, except for those submitted as p.m., Monday through Friday; they are efficacy endpoints for UC clinical trials. ‘‘Confidential Submissions,’’ publicly also available electronically at http:// DATES: Although you can comment on viewable at http://www.regulations.gov www.regulations.gov. FDA has verified any guidance at any time (see 21 CFR or at the Division of Dockets the Web site addresses, as of the date 10.115(g)(5)), to ensure that the Agency Management between 9 a.m. and 4 p.m., this document publishes in the Federal considers your comment on this draft Monday through Friday. Register, but Web sites are subject to guidance before it begins work on the • Confidential Submissions—To change over time. final version of the guidance, submit submit a comment with confidential either electronic or written comments information that you do not wish to be 1. FDA, ‘‘CDRH 2014–2015 Strategic Priorities,’’ 2014, http://www.fda.gov/ on the draft guidance by October 7, made publicly available, submit your downloads/AboutFDA/CentersOffices/ 2016. comments only as a written/paper OfficeofMedicalProductsandTobacco/ ADDRESSES: You may submit comments submission. You should submit two CDRH/CDRHVisionandMission/ as follows: copies total. One copy will include the UCM384576.pdf. information you claim to be confidential 2. ‘‘Guidance for Industry and FDA Staff: Electronic Submissions with a heading or cover note that states Balancing Premarket and Postmarket Data Collection for Devices Subject to Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Premarket Approval,’’ April 2015, http:// following way: CONFIDENTIAL INFORMATION.’’ The www.fda.gov/ucm/groups/fdagov-public/ • Federal eRulemaking Portal: http:// Agency will review this copy, including @fdagov-meddev-gen/documents/ www.regulations.gov. Follow the the claimed confidential information, in document/ucm393994.pdf. instructions for submitting comments. its consideration of comments. The 3. ‘‘Guidance for Industry and FDA Staff: Comments submitted electronically, second copy, which will have the Expedited Access for Premarket including attachments, to http:// claimed confidential information Approval and De Novo Medical Devices www.regulations.gov will be posted to redacted/blacked out, will be available Intended for Unmet Medical Need for the docket unchanged. Because your for public viewing and posted on http:// Life Threatening or Irreversibly Debilitating Diseases or Conditions,’’ comment will be made public, you are www.regulations.gov. Submit both April 2015, http://www.fda.gov/ucm/ solely responsible for ensuring that your copies to the Division of Dockets groups/fdagov-public/@fdagov-meddev- comment does not include any Management. If you do not wish your gen/documents/document/ confidential information that you or a name and contact information to be ucm393978.pdf. third party may not wish to be posted, made publicly available, you can 4. ‘‘Second and final cohort of Results of the such as medical information, your or provide this information on the cover 2014–2015 Strategic Priority: Strike the anyone else’s Social Security number, or sheet and not in the body of your Right Balance between Premarket and confidential business information, such comments and you must identify this Postmarket Data Collection, ’’ available as a manufacturing process. Please note information as ‘‘confidential.’’ Any at http://www.fda.gov/AboutFDA/ CentersOffices/ that if you include your name, contact information marked as ‘‘confidential’’ OfficeofMedicalProductsandTobacco/ information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other mstockstill on DSK3G9T082PROD with NOTICES CDRH/CDRHVisionandMission/ default.htm. comments, that information will be applicable disclosure law. For more posted on http://www.regulations.gov. information about FDA’s posting of Dated: August 2, 2016. • If you want to submit a comment comments to public dockets, see 80 FR Leslie Kux, with confidential information that you 56469, September 18, 2015, or access Associate Commissioner for Policy. do not wish to be made available to the the information at: http://www.fda.gov/ [FR Doc. 2016–18672 Filed 8–5–16; 8:45 am] public, submit the comment as a regulatoryinformation/dockets/ BILLING CODE 4164–01–P written/paper submission and in the default.htm. VerDate Sep<11>2014 22:23 Aug 05, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1


Document Created: 2016-08-06 03:08:26
Document Modified: 2016-08-06 03:08:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments.
DatesSubmit either electronic or written comments by October 7, 2016.
ContactNancy Braier, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-796-5676.
FR Citation81 FR 52445 
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