80 FR 23798 - 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 80, Issue 82 (April 29, 2015)

Page Range		23798-23801
FR Document		2015-09884

The Food and Drug Administration (FDA) is announcing the progress of the Center for Devices and Radiological Health (CDRH) on its 2014-2015 Strategic Priority ``Strike the Right Balance Between Premarket and Postmarket Data Collection.'' To achieve this 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, and established a target date of December 31, 2014, by which to review 50 percent of product codes subject to a premarket approval application (PMA) that are legally marketed to determine whether or not, based on our current understanding of the technology, to rely on postmarket controls to reduce premarket data collection, to shift some premarket data collection to the postmarket setting, or to pursue down-classification. CDRH has taken such actions periodically in the past consistent with the medical device statutory framework but typically has done so on an ad hoc basis. CDRH also will require more data or up-classify a device, if warranted, based on the current state of the science; however, up- classification is not warranted for the devices subject to this retrospective review because they are already in the highest risk classification. In this document, CDRH is providing its current thinking on reviewed product types to solicit comments on the product codes that have been identified as candidates for reclassification, for reliance on postmarket controls to reduce premarket data collection, or a shift in premarket data collection to the postmarket setting.

Federal Register, Volume 80 Issue 82 (Wednesday, April 29, 2015)

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23798-23801]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-09884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0090]

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
progress of the Center for Devices and Radiological Health (CDRH) on
its 2014-2015 Strategic Priority ``Strike the Right Balance Between
Premarket and Postmarket Data Collection.'' To achieve this 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, and established a target date of
December 31, 2014, by which to review 50 percent of product codes
subject to a premarket approval application (PMA) that are legally
marketed to determine whether or not, based on our current
understanding of the technology, to rely on postmarket controls to
reduce premarket data collection, to shift some premarket data
collection to the postmarket setting, or to pursue down-classification.
CDRH has taken such actions periodically in the past consistent with
the medical device statutory framework but typically has done so on an
ad hoc basis. CDRH also will require more data or up-classify a device,
if warranted, based on the current state of the science; however, up-
classification is not warranted for the devices subject to this
retrospective review because they are already in the highest risk
classification. In this document, CDRH is providing its current
thinking on reviewed product types to solicit comments on the product
codes that have been identified as candidates for reclassification, for
reliance on postmarket controls to reduce premarket data collection, or
a shift in premarket data collection to the postmarket setting.

DATES: Submit either electronic or written comments by June 29, 2015.
See section IV for more information on how to submit comments to this
document and properly identify the device(s) the comment concerns.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Identify comments with the docket number found in
brackets in the heading of this document and with the product code(s)
for the device(s) the comment concerns.

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 is 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 is sufficient data to demonstrate a reasonable
assurance of safety and effectiveness before a device 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 CDRH shifted some data
collection from the premarket to the postmarket setting without
adequate assurances that necessary and timely 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 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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[[Page 23799]]

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 draft guidance, ``Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket Approval''
on April 23, 2014 (78 FR 22690). This draft guidance proposed an FDA
policy of balancing premarket and postmarket data collection during the
Agency's review of PMAs. This guidance outlined 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. Comments on this
draft guidance were collected through July 22, 2014, and the guidance
was finalized on April 13, 2015 (Ref. 2). Furthermore, under existing
authorities, CDRH and CBER issued a draft guidance document on April
23, 2014 (78 FR 22691), entitled ``Expedited Access for Premarket
Approval Medical Devices Intended for Unmet Medical Need for Life
Threatening or Irreversibly Debilitating Diseases or Conditions.'' This
draft guidance described FDA's proposal for a new, 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 would shift appropriate premarket data
collection to the postmarket setting while maintaining the statutory
standard of a reasonable assurance of safety and effectiveness.
Comments on this draft guidance were collected through July 22, 2014,
and the guidance was finalized and issued on April 13, 2015 (Ref. 3).
In addition, CDRH is currently developing a mechanism to prospectively
assure the appropriate balance of premarket and postmarket data
collection for new devices subject to a PMA.
Another action in pursuit of the goal to strike the right balance
between premarket and postmarket data collection is 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, 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, CDRH routinely requires more data when warranted based
on our current understanding of that type of technology or based on
issued 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, in May 2014, CDRH proposed to up-
classify surgical mesh when intended for use for pelvic organ prolapse
(79 FR 24634), and in June 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, the devices are analyzed
according to procode. CDRH targeted the date of December 31, 2014, to
review 50 percent of procodes subject to a PMA that are legally
marketed to determine whether or not to change premarket data
collection by shifting to the postmarket setting, reducing premarket
data collection through reliance on postmarket controls, or pursuing
reclassification (Ref. 1). This target extends to have 75 percent
completed by June 30, 2015, and 100 percent completed by December 31,
2015.
The purpose of this Federal Register notice is to solicit comments
on the 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, 2014. 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. Progress Toward Goal Targets

Retrospective analysis of the class III medical device procodes is
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 associated with the technology of each
device, the type and amount of data that is needed to demonstrate a
reasonable assurance of safety and effectiveness evolve. This evolution
to require the least burdensome amount of data to evaluate device
effectiveness follows 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 which 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

[[Page 23800]]

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, 2014, CDRH reviewed 69 percent
of the procodes included in this retrospective review, exceeding its 50
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 at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm. As discussed in further detail, 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 2014, 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 a device is a good
candidate for a change in data collection or reclassification included
if risks are now well understood and 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 if there
have been significant changes implemented to address safety or
effectiveness since the devices have been on the market or if the
review of annual reports and manufacturing changes has been important
to maintain safety of the devices. Furthermore, if there were a limited
number of approvals or limited clinical use of the devices, this was
considered an additional unfavorable factor for the devices to be
considered candidates for a change in data collection or
reclassification, 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)
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) according to public health impact and Center
resources, in order to determine which reductions of or shifts to data
collection would have the greatest impact. The 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. Comments

Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document and the product
code(s) for the device(s) the comment concerns. Citizen petitions and
petitions for reclassification should not be submitted to the docket.
Rather, for instructions on how to appropriately submit citizen
petitions and petitions for reclassification, please see 21 CFR 10.30
and 860.123, respectively. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

V. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. FDA, ``CDRH 2014-2015 Strategic Priorities,'' 2014, available at
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM384576.pdf.

[[Page 23801]]

2. ``Guidance for Industry and FDA Staff: Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket
Approval,'' April 2015, available at 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, available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393978.pdf.

Dated: April 22, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-09884 Filed 4-28-15; 8:45 am]
BILLING CODE 4164-01-P

23798 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices

scheduled between approximately 2:30 SUMMARY: The Food and Drug Ave., Bldg. 66, Rm. 5454, Silver Spring,
p.m. and 3:30 p.m. Those individuals Administration (FDA) is announcing the MD 20993–0002, 301–796–5676.
interested in making formal oral progress of the Center for Devices and
SUPPLEMENTARY INFORMATION:
presentations should notify the contact Radiological Health (CDRH) on its
person and submit a brief statement of 2014–2015 Strategic Priority ‘‘Strike the I. Background
the general nature of the evidence or Right Balance Between Premarket and
arguments they wish to present, the Postmarket Data Collection.’’ To achieve One of three Strategic Priorities for
names and addresses of proposed this priority, CDRH established a goal to 2014–2015 in CDRH is to ‘‘Strike the
participants, and an indication of the assure the appropriate balance between Right Balance Between Premarket and
approximate time requested to make premarket and postmarket data Postmarket Data Collection’’ (Ref. 1).1
their presentation on or before May 15, collection to facilitate and expedite the CDRH’s vision is for patients in the
2015. Time allotted for each development and review of medical United States to have first in the world
presentation may be limited. If the devices, in particular high-risk devices access to high-quality, safe, and
number of registrants requesting to of public health importance, and effective medical devices of public
speak is greater than can be reasonably established a target date of December 31, health importance. A key determinant of
accommodated during the scheduled 2014, by which to review 50 percent of early U.S. patient access to high-quality,
open public hearing session, FDA may product codes subject to a premarket safe, and effective devices is the extent
conduct a lottery to determine the approval application (PMA) that are of premarket data that device developers
speakers for the scheduled open public legally marketed to determine whether provide to FDA. Once a device
hearing session. The contact person will or not, based on our current developer decides to seek U.S.
notify interested persons regarding their understanding of the technology, to rely marketing approval or clearance, the
request to speak by May 18, 2015. on postmarket controls to reduce extent of data that is collected
Persons attending FDA’s advisory premarket data collection, to shift some premarket has an impact upon the
committee meetings are advised that the premarket data collection to the length of time needed to complete a
Agency is not responsible for providing postmarket setting, or to pursue down- premarket submission—the more data to
access to electrical outlets. classification. CDRH has taken such be collected premarket, the longer it
FDA welcomes the attendance of the actions periodically in the past may take to acquire the data and make
public at its advisory committee consistent with the medical device the submission. Consequently, such
meetings and will make every effort to statutory framework but typically has data collection issues affect when U.S.
accommodate persons with physical done so on an ad hoc basis. CDRH also patients have access to a medical
disabilities or special needs. If you will require more data or up-classify a device. On the other hand, it is also
require special accommodations due to device, if warranted, based on the important that there is sufficient data to
a disability, please contact Bryan Emery current state of the science; however, demonstrate a reasonable assurance of
at least 7 days in advance of the up-classification is not warranted for the safety and effectiveness before a device
meeting. devices subject to this retrospective subject to a premarket approval
FDA is committed to the orderly review because they are already in the application (PMA) is approved for
conduct of its advisory committee highest risk classification. In this marketing in the United States. For this
meetings. Please visit our Web site at document, CDRH is providing its reason, it is important that CDRH strike
http://www.fda.gov/Advisory current thinking on reviewed product the right balance between premarket
Committees/AboutAdvisoryCommittees/ types to solicit comments on the and postmarket data collection. If CDRH
ucm111462.htm for procedures on product codes that have been identified can shift—when appropriate—some
public conduct during advisory as candidates for reclassification, for premarket data collection to the
committee meetings. reliance on postmarket controls to postmarket setting, CDRH could
Notice of this meeting is given under reduce premarket data collection, or a improve patient access to high-quality,
the Federal Advisory Committee Act (5 shift in premarket data collection to the safe, and effective medical devices of
U.S.C. app. 2). postmarket setting. public health importance. However,
Dated: April 24, 2015. patient safety could be undermined if
DATES: Submit either electronic or
Peter Lurie, CDRH shifted some data collection from
written comments by June 29, 2015. See
Associate Commissioner for Public Health the premarket to the postmarket setting
section IV for more information on how
Strategy and Analysis. without adequate assurances that
to submit comments to this document
[FR Doc. 2015–10026 Filed 4–28–15; 8:45 am] necessary and timely data collection
and properly identify the device(s) the
will occur. For this reason, CDRH
BILLING CODE 4164–01–P comment concerns.
strives to balance the premarket data
ADDRESSES: Submit electronic and postmarket collection, in
DEPARTMENT OF HEALTH AND comments to http:// accordance with section 513(a)(3)(C) (21
HUMAN SERVICES www.regulations.gov. Submit written U.S.C. 360c(a)(3)(C)) of the Federal
comments to the Division of Dockets Food, Drug, and Cosmetic Act (the
Food and Drug Administration Management (HFA–305), Food and Drug FD&C Act), which directs CDRH to
Administration, 5630 Fishers Lane, Rm. consider whether the extent of data that
[Docket No. FDA–2014–D–0090]
1061, Rockville, MD 20852. Identify otherwise would be required for
Retrospective Review of Premarket comments with the docket number approval of a PMA with respect to
mstockstill on DSK4VPTVN1PROD with NOTICES

Approval Application Devices; Striking found in brackets in the heading of this effectiveness can be reduced through
the Balance Between Premarket and document and with the product code(s) reliance on postmarket controls.
Postmarket Data Collection for the device(s) the comment concerns.
1 CDRH’s 2014–2015 Strategic Priorities include
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
‘‘Strengthen the Clinical Trial Enterprise’’ and
HHS. Nancy Braier, Center for Devices and ‘‘Provide Excellent Customer Service,’’ in addition
Radiological Health, Food and Drug to ‘‘Strike the Right Balance Between Premarket and
ACTION: Notice; request for comments.
Administration, 10903 New Hampshire Postmarket Data Collection’’ (Ref. 1).

VerDate Sep<11>2014 17:18 Apr 28, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1

Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices 23801

2. ‘‘Guidance for Industry and FDA Staff: Evaluation and Research, Food and Xience Xpedition Everolimus Eluting
Balancing Premarket and Postmarket Drug Administration, 10001 New Coronary Stent System represented the
Data Collection for Devices Subject to Hampshire Ave., Hillandale Campus, first permitted commercial marketing or
Premarket Approval,’’ April 2015,
Rm. 3180, Silver Spring, MD 20993– use of the product. Thereafter, the
available at http://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddev- 0002, 301–796–7900. USPTO requested that FDA determine
gen/documents/document/ SUPPLEMENTARY INFORMATION: The Drug the product’s regulatory review period.
ucm393994.pdf. Price Competition and Patent Term FDA has determined that the
3. ‘‘Guidance for Industry and FDA Staff: Restoration Act of 1984 (Pub. L. 98–417) applicable regulatory review period for
Expedited Access for Premarket and the Generic Animal Drug and Patent Xience Xpedition Everolimus Eluting
Approval and De Novo Medical Devices Coronary Stent System is 178 days. Of
Term Restoration Act (Pub. L. 100–670)
Intended for Unmet Medical Need for this time, zero (0) days occurred during
Life Threatening or Irreversibly generally provide that a patent may be
Debilitating Diseases or Conditions,’’ extended for a period of up to 5 years the testing phase of the regulatory
April 2015, available at http://www.fda. so long as the patented item (human review period, while 178 days occurred
gov/ucm/groups/fdagov-public/@fdagov- drug product, animal drug product, during the approval phase. These
meddev-gen/documents/document/ medical device, food additive, or color periods of time were derived from the
ucm393978.pdf. additive) was subject to regulatory following dates:
Dated: April 22, 2015. review by FDA before the item was 1. The date an exemption under
Peter Lurie, marketed. Under these acts, a product’s section 520(g) of the Federal Food, Drug,
Associate Commissioner for Public Health regulatory review period forms the basis and Cosmetic Act (the FD&C Act) (21
Strategy and Analysis. for determining the amount of extension U.S.C. 360j(g)) involving this device
[FR Doc. 2015–09884 Filed 4–28–15; 8:45 am] an applicant may receive. became effective: Not Applicable.
A regulatory review period consists of Applicant did not perform clinical
BILLING CODE 4164–01–P
two periods of time: A testing phase and investigations utilizing the patented
an approval phase. For medical devices, device, but, rather, sought and was
DEPARTMENT OF HEALTH AND the testing phase begins with a clinical granted marketing approval based on a
HUMAN SERVICES investigation of the device and runs supplemental filing to a previously
until the approval phase begins. The approved premarket approval
Food and Drug Administration approval phase starts with the initial application (PMA).
submission of an application to market 2. The date an application was
[Docket No. FDA–2014–E–0102]
the device and continues until initially submitted with respect to the
Determination of Regulatory Review permission to market the device is device under section 515 of the FD&C
Period for Purposes of Patent granted. Although only a portion of a Act (21 U.S.C. 360e): June 27, 2012. FDA
Extension; Xience Xpedition regulatory review period may count has verified the applicant’s claim that
Everolimus Eluting Coronary Stent toward the actual amount of extension the PMA for Xience Xpedition
System that the Director of Patents and Everolimus Eluting Coronary Stent
Trademarks may award (half the testing System (PMA P110019S025) was
AGENCY: Food and Drug Administration, phase must be subtracted as well as any initially submitted June 27, 2012.
HHS. time that may have occurred before the 3. The date the application was
ACTION: Notice. patent was issued), FDA’s determination approved: December 21, 2012. FDA has
of the length of a regulatory review verified the applicant’s claim that PMA
SUMMARY: The Food and Drug period for a medical device will include P110019S025 was approved on
Administration (FDA) has determined all of the testing phase and approval December 21, 2012.
the regulatory review period for Xience phase as specified in 35 U.S.C. This determination of the regulatory
Xpedition Everolimus Eluting Coronary 156(g)(3)(B). review period establishes the maximum
Stent System and is publishing this FDA has approved for marketing the potential length of a patent extension.
notice of that determination as required medical device, Xience Xpedition However, the USPTO applies several
by law. FDA has made the Everolimus Eluting Coronary Stent statutory limitations in its calculations
determination because of the System. Xience Xpedition Everolimus of the actual period for patent extension.
submission of an application to the Eluting Coronary Stent System is In its application for patent extension,
Director of the U.S. Patent and indicated for improving coronary this applicant seeks 178 days of patent
Trademark Office (USPTO), Department luminal diameter in subjects with term extension.
of Commerce, for the extension of a symptomatic heart disease due to de Anyone with knowledge that any of
patent which claims that medical novo native coronary artery lesions the dates as published are incorrect may
device. (length ≤32 millimeters (mm)) with submit to the Division of Dockets
ADDRESSES: Submit electronic reference vessel diameter of ≥2.25 mm Management (see ADDRESSES) either
comments to http:// and ≤4.25 mm. Subsequent to this electronic or written comments and ask
www.regulations.gov. Submit written approval, the USPTO received a patent for a redetermination by June 29, 2015.
petitions (two copies are required) and term restoration application for Xience Furthermore, any interested person may
written comments to the Division of Xpedition Everolimus Eluting Coronary petition FDA for a determination
Dockets Management (HFA–305), Food Stent System (U.S. Patent No. 7,828,766) regarding whether the applicant for
and Drug Administration, 5630 Fishers
mstockstill on DSK4VPTVN1PROD with NOTICES

from Abbott Cardiovascular Systems extension acted with due diligence
Lane, Rm. 1061, Rockville, MD 20852. Inc., and the USPTO requested FDA’s during the regulatory review period by
Submit petitions electronically to assistance in determining this patent’s October 26, 2015. To meet its burden,
http://www.regulations.gov at Docket eligibility for patent term restoration. In the petition must contain sufficient facts
No. FDA–2013–S–0610. a letter dated May 22, 2014, FDA to merit an FDA investigation. (See H.
FOR FURTHER INFORMATION CONTACT: advised the USPTO that this medical Rept. 857, part 1, 98th Cong., 2d sess.,
Beverly Friedman, Office of device had undergone a regulatory pp. 41–42, 1984.) Petitions should be in
Management, Center for Drug review period and that the approval of the format specified in 21 CFR 10.30.

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Document Created: 2015-12-16 08:26:30
Document Modified: 2015-12-16 08:26:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; request for comments.
Dates		Submit either electronic or written comments by June 29, 2015. See section IV for more information on how to submit comments to this document and properly identify the device(s) the comment concerns.
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.
FR Citation		80 FR 23798

80 FR 23798 - Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 82 (April 29, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration