80 FR 81335 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 249 (December 29, 2015)

The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 2016. In addition, FDA has established a docket, where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide early input to support guidances that will be developed.

[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81335-81339]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]


Medical Device User Fee and Modernization Act; Notice to Public 
of Web Site Location of Fiscal Year 2016 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the Web site location where the Agency will post two lists 
of guidance documents that the Center for Devices and Radiological 
Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 
2016. In addition, FDA has established a docket, where interested 
persons may comment on the priority of topics for guidance, provide 
comments and/or propose draft language for those topics, suggest topics 
for new or different guidance documents, comment on the applicability 
of guidance documents that have issued previously, and provide early 
input to support guidances that will be developed.

DATES: Although you can comment on any guidance at any time, submit 
either electronic or written comments by February 29, 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-1021 for ``Medical Device User Fee and Modernization Act; 
Notice to Public of Web site Location of Fiscal Year 2016 Proposed 
Guidance Development.'' 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

[[Page 81336]]

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: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration,10903 New Hampshire 
Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations on the Medical Device User Fee Amendments of 
2012 (MDUFA III), Title II, Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-114), FDA agreed to meet a variety of 
quantitative and qualitative goals intended to help get safe and 
effective medical devices to market more quickly. Among these 
commitments included:
     Annually posting a list of priority medical device 
guidance documents that the Agency intends to publish within 12 months 
of the date this list is published each fiscal year (the ``A-list'') 
and
     annually posting a list of device guidance documents that 
the Agency intends to publish, as the Agency's guidance-development 
resources permit each fiscal year (the ``B-list'').
    FDA invites interested persons to submit comments on any or all of 
the guidance documents on the lists as explained in 21 CFR 
10.115(f)(5). FDA has established the docket number (FDA-2012-N-1021) 
where comments on the FY 2016 lists, draft language for guidance 
documents on those topics, suggestions for new or different guidances, 
and relative priority of guidance documents may be submitted and shared 
with the public (see ADDRESSES). FDA believes this docket is an 
important tool for receiving information from interested persons and 
will update these lists annually on FDA's Web site at the beginning of 
each fiscal year from 2013 to 2017. FDA anticipates that feedback from 
interested persons, will allow CDRH to better prioritize and more 
efficiently draft guidances.
    In addition to posting the lists of prioritized device guidance 
documents, FDA has committed to updating its Web site in a timely 
manner to reflect the Agency's review of previously published guidance 
documents; including, the deletion of guidance documents that no longer 
represent the Agency's interpretation of or policy on a regulatory 
issue and notation of guidance documents that are under review by the 
Agency.
    Fulfillment of these commitments will be reflected through the 
issuance of updated guidance on existing topics, removal of guidances 
that that no longer reflect FDA's current thinking on a particular 
topic, and annual updates to the A-list and B-list announced in this 
notice.

II. CDRH Guidance Development Initiative

    On June 5, 2014, CDRH held a public workshop to provide 
stakeholders (e.g., industry, academia, public health advocacy groups, 
and other interested persons) an opportunity to actively engage with 
Center representatives about the guidance development process, provide 
transparency into guidance priority development, promote dialogue on 
guidance process improvements, and generate ideas for assessing the 
impact of guidance (Ref. 1). The workshop also provided a forum to 
discuss best practices and public participation in guidance 
development. CDRH carefully considered the comments and suggestions 
provided by stakeholders.
    At the 2014 workshop, stakeholders requested that draft guidance 
documents be more clearly identified as ``draft'' to indicate to CDRH 
stakeholders and staff that they are not for implementation. CDRH 
revised its templates for new draft guidance documents by adding the 
watermark ``DRAFT'' to all pages in order to more conspicuously mark 
the guidance as not for implementation. CDRH implemented the use of the 
new templates effective August 6, 2014, and continues to use these 
templates.
    Stakeholders also recommended that CDRH's guidance documents Web 
page (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm) list draft guidances separately from 
those that had been finalized. CDRH revised its guidance document Web 
page to include a left navigation item for ``Draft Guidance.'' In 
addition, CDRH removed draft guidance documents from the office 
guidance document lists and separated the link to ``Recent Medical 
Device Guidance Documents'' into two separate links: ``Recent Medical 
Device Final Guidance Documents'' and ``Recent Medical Device Draft 
Guidance Documents.''
    CDRH is aware of draft guidance documents yet to be finalized. 
Therefore, in order to assure the timely completion or re-issuance of 
draft guidances in FY 2015, CDRH committed to performance goals for 
current and future draft guidance documents. For draft guidance 
documents issued after October 1, 2014, CDRH committed to finalize, 
withdraw, reopen the comment period or issue another draft guidance on 
the topic for 80 percent of the documents within 2 years of the close 
of the comment period and for the remaining 20 percent, within 5 years. 
In FY 2015, CDRH has withdrawn 14 of 20 draft guidances issued prior to 
October 1, 2009, and has been continuing to work towards finalizing the 
remaining draft guidances. Furthermore, in FY 2016, CDRH will finalize, 
withdraw, or reopen the comment period for 50 percent of existing draft 
guidances issued prior to October 1, 2010, CDRH expects to renew or 
modify, as appropriate, these performance goals in FY 2017 and 
subsequent years.

A. Earlier Stakeholder Involvement in Guidance Development

    At the 2014 workshop, stakeholders also expressed a desire to be 
involved earlier in the guidance development process. CDRH 
representatives discussed various ways in which the Center currently 
encourages participation by external stakeholders in the guidance 
development process. In the case of emerging technologies, CDRH uses 
``leapfrog'' guidances to provide initial recommendations regarding the 
type of information that would be appropriate in the review of these 
emerging technologies. Input from external stakeholders help CDRH

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formulate its initial thinking on the data necessary to support 
marketing approval, clearance, or oversight of these devices. In FY 
2015, CDRH issued two leapfrog draft guidances, ``Premarket Studies of 
Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices'' (Ref. 
2) and Radiation Biodosimetry Devices (Ref. 3). For the Premarket 
Studies of Implantable MIGS Device guidance document, early stakeholder 
input was obtained through discussions with glaucoma specialists 
identified by the American Glaucoma Society through the Network of 
Experts (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm289534.htm), as well as 
through a workshop cosponsored with the American Glaucoma Society on 
February 26, 2014 (Ref. 4). In addition, early stakeholder feedback was 
obtained at a public workshop for the Radiation Biodosimetry Devices 
guidance document (Ref. 5).
    Additionally, in FY 2015, in anticipation of guidance documents 
expected to be developed, CDRH sought stakeholder input regarding 
Patient Matched Instrumentation for Orthopedics, Medical Devices 
Intended for Aesthetic Use, and Dual 510(k) and Clinical Laboratory 
Improvement Amendments Act (CLIA) Waiver by Application. The feedback 
received has been considered in the development of these guidances and 
CDRH has included the Dual 510(k) and CLIA Waiver by Application 
guidance and Patient Matched Instrumentation for Orthopedics on the 
FY2016 B-List.
    CDRH is posing the following questions to interested persons for 
consideration and comment, so that relevant future draft guidances on 
these technologies can be as complete and useful as possible. We will 
carefully consider the comments received in the development of new 
guidance documents and incorporate the information where appropriate. 
CDRH believes that public input during guidance development and after a 
draft guidance is issued on the topic will lead to a comprehensive and 
informed final guidance on the Agency's policy for the technologies and 
processes in the following list:
1. Electromagnetic Compatibility (EMC) of Electrically-Powered Medical 
Devices
    EMC assessment is a vital part of ensuring that risks associated 
with performance degradation of electrically-powered medical devices 
associated with electromagnetic interference are adequately addressed. 
CDRH recently published a short draft guidance entitled ``Information 
to Support a Claim of Electromagnetic Compatibility (EMC) of 
Electrically-Powered Medical Devices'' (Ref. 6) to provide a framework 
for promoting consistent submission and review of EMC information in 
premarket submissions. In addition, CDRH plans to also draft a more 
detailed guidance on this topic guidance to provide more comprehensive 
information and transparency to stakeholders regarding the information 
necessary to support an EMC claim. FDA invites comments on the 
following questions:
    a. There has been increasing use of electromagnetic emitters (e.g., 
radio-frequency identification, electronic article surveillance gates, 
metal detectors) in the environments where medical devices operate. 
What methods are used to determine EMC of devices exposed to these 
common emitters?
    b. Given that basic safety, as defined in the IEC 60601-1 family of 
standards, does not include effectiveness, how is device performance 
evaluated differently than device safety for EMC? Specifically, are 
pass/fail criteria chosen such that they will address both performance 
and safety for each EMC test? Alternatively, are safety and performance 
tested separately?
    c. When networks (wired or wireless) are determined to be necessary 
for device performance, how are they included as a system when tested 
for EMC?
    d. The use of ``third party'' components can significantly affect 
the EMC of the medical device system. How are device systems evaluated 
for EMC when off-the-shelf components such as smartphones, tablets, or 
PCs are intended to be used in the device system?
    e. Medical devices, like most electronic products, go through 
various design changes that can affect the EMC of the device system. 
The changes or modifications can occur after initial EMC testing. What 
factors and methods are used to determine how device changes or 
modifications (e.g., software, firmware, hardware) will affect EMC and 
how is it determined when partial or complete EMC re-testing of a 
device is needed?
    f. The use of magnetic resonance (MR) imaging technology on medical 
device users and patients is increasing. MR imaging incorporates very 
strong magnetic and electric fields that can have very significant 
effects on the safety and effectiveness of medical devices, especially 
electrically active devices. How is MR safety and compatibility 
addressed for electrically active medical devices intended for use in 
the MR environment? How is MR safety addressed (e.g. labeling or other) 
for electrically active medical devices not intended for use in the MR 
environment?
    g. Several medical device EMC consensus standards specify the 
information to be conveyed to the user regarding device EMC. Is this 
information sufficient? If not, what additional type of information is 
typically provided to help the user manage the risks associated with 
medical device EMC and how is this information conveyed?
2. Utilizing Animal Studies To Evaluate the Safety of Organ 
Preservation Devices and Solutions
    While the national transplant waiting list continues to grow, rates 
of donation and transplant remain stagnant. On average, 22 people die 
each day waiting for a transplant. The dire deficit in organ 
transplants has propelled a new wave of innovation in perfusion-based 
organ preservation technologies. With such innovation also comes the 
challenge of demonstrating that these new technologies, when evaluated 
in animal models, are sufficiently safe for early clinical experience.
    After animal organs undergo preservation using a new organ 
transport device or solution, there are generally two models to assess 
post-reperfusion injury: (1) An in vivo model in which the organ is 
transplanted into a surrogate recipient animal and (2) an ex vivo model 
in which the organ is reperfused under simulated transplant conditions. 
FDA intends to develop guidance to provide recommendations for 
utilizing both in vivo and ex vivo models to evaluate emerging organ 
preservation technologies. Prior to drafting our recommendations in a 
future guidance document, FDA invites comments on the following 
questions:
    a. What are the potential limitations of an ex vivo model in 
assessing reperfusion injury, and how can these limitations be 
mitigated? In addition to markers for cell injury and function, 
histology, and the use of allogeneic blood during reperfusion, what 
measures can be taken to improve the data generated in an ex vivo 
model?
    b. In an in vivo model, what are strategies to limit confounding 
factors, such as immunological responses and hemodynamic instability, 
from affecting the assessment of device-related reperfusion injury?
    c. Is there a perceived hierarchy of evidence regarding data 
obtained from an ex vivo model and those obtained from an in vivo 
model? Or rather, is it

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more judicious to view the two models as complements of each other?
    d. What role does the risk of the device play in the utilization of 
in vivo and ex vivo models? Regarding specific experimental parameters 
(e.g., length of preservation, total ischemic time), under what 
circumstances is it appropriate to test the worst-case scenario?
    e. What are the organ-specific challenges in developing in vivo and 
ex vivo models to assess reperfusion injury?
    f. What approaches would improve the in vivo and ex vivo study 
designs to ensure the generation of sufficient, meaningful data while 
limiting the number of animals used in such studies?

B. Stakeholder Feedback To Enhance the CDRH Guidance Program

    In addition, to enhance the CDRH guidance program, CDRH invites 
interested persons to comment on the following questions:
    a. The cover page of each guidance document includes contact 
information for questions regarding the guidance, and a list of CDRH 
Offices that have generally contributed to the drafting of the 
guidance. Is the list of CDRH Offices involved in the drafting of the 
guidance informative? What other administrative information should be 
included on the cover page?
    b. CDRH is committed to the continual improvement of the quality of 
guidance documents and we are seeking to identify examples of quality 
guidance documents. Are there specific guidance documents published in 
the past 5 years that were particularly informative and helpful that 
could serve as models for future guidance documents? Please provide the 
title of the guidance documents and briefly describe what specific 
aspects were informative and helpful?
    c. Has the enhanced Guidance Document Search feature on the FDA Web 
site (http://www.fda.gov/RegulatoryInformation/Guidances/default.htm) 
improved searchability of guidances? Are there any suggestions for how 
the search feature could be improved?

C. Applicability of Previously-Issued Final Guidance

    CDRH has issued over 1,000 guidance documents to provide 
stakeholders with the Agency's thinking on numerous topics. Each 
guidance reflected the Agency's current position at the time that it 
was issued. However, the guidance program has issued these guidances 
over a period greater than 20 years, raising the question of how 
current do previously issued final guidances remain? CDRH has resolved 
to address this concern through a staged review of previously issued 
final guidances in collaboration with stakeholders.
    At the Web site where CDRH has posted the ``A-list'' and ``B-list'' 
for FY 2016, CDRH has also posted a list of final guidance documents 
that issued in 2006, 1996, 1986, and 1976.\1\
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    \1\ The retrospective list of final guidances does not include: 
(1) Documents that are not guidances but were inadvertently 
categorized as guidance such as scientific publications, advisory 
opinions, and interagency agreements; (2) guidances actively being 
revised by CDRH; and (3) special controls documents.
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    The Center is interested in external feedback on whether any of 
these final guidances should be revised or withdrawn. In addition, for 
guidances that are recommended for revision, information explaining the 
need for revision, such as, the impact and risk to public health 
associated with not revising the guidance, would also be helpful as the 
Center considers potential action with respect to these guidances. CDRH 
intends to provide these lists of previously-issued final guidances 
annually through FY 2025 so that by 2025, FDA and stakeholders will 
have assessed the applicability of all guidances older than 10 years. 
For instance, in the annual notice for FY 2017, CDRH expects to provide 
a list of the final guidance documents that issued in 2007, 1997, 1987, 
and 1977; the annual notice for FY 2018 is expected to provide a list 
of the final guidance documents that issued in 2008, 1998, 1988, and 
1978, and so on. CDRH will consider the comments received from this 
retrospective review when determining priorities for updating guidance 
documents, and will revise these as resources permit. During FY 2015, 
CDRH received comments regarding guidances issued in 2005, 1995, and 
1985, and is considering further actions on specific guidances in 
response to comments received.
    Under the Good Guidance Practices regulation at Sec.  10.115(f)(4), 
the public may, at any time, suggest that CDRH revise or withdraw an 
already existing guidance document. The suggestion should clearly 
explain why the guidance document should be revised or withdrawn and, 
if applicable, how it should be revised. Interested persons are 
requested to examine the list of previously issued final guidances 
provided by CDRH on the annual agenda Web site but feedback on any 
guidance is appreciated.

III. Web Site Location of Guidance Lists

    This notice announces the Web site location of the document that 
provides the A and B lists of guidance documents, which CDRH is 
intending to publish during FY 2016. To access these two lists, visit 
FDA's Web site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm. We note 
that the topics on this and past guidance priority lists may be removed 
or modified based on current priorities. The Agency is not required to 
publish every guidance on either list if the resources needed would be 
to the detriment of meeting quantitative review timelines and statutory 
obligations. In addition, the Agency is not precluded from issuing 
guidance documents that are not on either list.
    FDA and CDRH priorities are subject to change at any time. Topics 
on this and past guidance priority lists may be removed or modified 
based on current priorities. CDRH's experience in guidance development 
has shown that there are many reasons that CDRH staff may not complete 
the entire agenda of guidances it undertakes. Staff is frequently 
diverted from guidance development to other priority activities. In 
addition, at any time new issues may arise to be addressed in guidance 
that could not have been anticipated at the time the annual list is 
generated. These may involve newly identified public health issues.

IV. References

    The following references are 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. Center for Devices and Radiological Health Guidance Development 
and Prioritization; Public Workshop; Requests for Comments, 
available at http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm394821.htm.
2. Premarket Studies of Implantable Minimally Invasive Glaucoma 
Surgical (MIGS) Devices Draft Guidance, available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm433165.pdf.
3. Radiation Biodosimetry Devices; Draft Guidance for Industry and 
Food and Drug Administration Staff, available at http://www.fda.gov/
downloads/MedicalDevices/

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DeviceRegulationandGuidance/GuidanceDocuments/UCM427866.pdf.
4. American Glaucoma Society/Food and Drug Administration Workshop 
on Supporting Innovation for Safe and Effective Minimally Invasive 
Glaucoma Surgery; Public Workshop, available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm382508.htm.
5. Regulatory Science Considerations for Medical Countermeasure 
Radiation Biodosimetry Devices, available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm308079.htm.
6. Information to Support a Claim of Electromagnetic Compatibility 
(EMC) of Electrically-Powered Medical Devices, available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm470201.pdf.

    Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32726 Filed 12-28-15; 8:45 am]
 BILLING CODE 4164-01-P