Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection, 23798-23801 [2015-09884]
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Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices
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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 downclassification. 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.
Dated: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
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.
[FR Doc. 2015–10026 Filed 4–28–15; 8:45 am]
BILLING CODE 4164–01–P
Submit electronic
comments to https://
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.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[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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FOR FURTHER INFORMATION CONTACT:
Nancy Braier, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
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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.
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 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
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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 (downclassified) 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 upclassifying 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
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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
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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 https://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
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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
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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 https://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 https://
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 https://
www.fda.gov/downloads/AboutFDA/
CentersOffices/OfficeofMedicalProducts
andTobacco/CDRH/CDRHVisionand
Mission/UCM384576.pdf.
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2. ‘‘Guidance for Industry and FDA Staff:
Balancing Premarket and Postmarket
Data Collection for Devices Subject to
Premarket Approval,’’ April 2015,
available at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddevgen/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 https://www.fda.
gov/ucm/groups/fdagov-public/@fdagovmeddev-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–0102]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Xience Xpedition
Everolimus Eluting Coronary Stent
System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for Xience
Xpedition Everolimus Eluting Coronary
Stent System and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Center for Drug
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SUMMARY:
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Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Campus,
Rm. 3180, Silver Spring, MD 20993–
0002, 301–796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a medical device will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the
medical device, Xience Xpedition
Everolimus Eluting Coronary Stent
System. Xience Xpedition Everolimus
Eluting Coronary Stent System is
indicated for improving coronary
luminal diameter in subjects with
symptomatic heart disease due to de
novo native coronary artery lesions
(length ≤32 millimeters (mm)) with
reference vessel diameter of ≥2.25 mm
and ≤4.25 mm. Subsequent to this
approval, the USPTO received a patent
term restoration application for Xience
Xpedition Everolimus Eluting Coronary
Stent System (U.S. Patent No. 7,828,766)
from Abbott Cardiovascular Systems
Inc., and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated May 22, 2014, FDA
advised the USPTO that this medical
device had undergone a regulatory
review period and that the approval of
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Xience Xpedition Everolimus Eluting
Coronary Stent System represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
Xience Xpedition Everolimus Eluting
Coronary Stent System is 178 days. Of
this time, zero (0) days occurred during
the testing phase of the regulatory
review period, while 178 days occurred
during the approval phase. These
periods of time were derived from the
following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360j(g)) involving this device
became effective: Not Applicable.
Applicant did not perform clinical
investigations utilizing the patented
device, but, rather, sought and was
granted marketing approval based on a
supplemental filing to a previously
approved premarket approval
application (PMA).
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): June 27, 2012. FDA
has verified the applicant’s claim that
the PMA for Xience Xpedition
Everolimus Eluting Coronary Stent
System (PMA P110019S025) was
initially submitted June 27, 2012.
3. The date the application was
approved: December 21, 2012. FDA has
verified the applicant’s claim that PMA
P110019S025 was approved on
December 21, 2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 178 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by June 29, 2015.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
October 26, 2015. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
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[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23798-23801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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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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
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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 https://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 https://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 https://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
https://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 https://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 https://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
