[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52445-52449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18672]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1805]
Retrospective Review of Premarket Approval Application Devices;
Striking the Balance Between Premarket and Postmarket Data Collection
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
completion of the target of the goal established to address the Center
for Devices and Radiological Health's (CDRH) 2014-2015 Strategic
Priority ``Strike the Right Balance Between Premarket and Postmarket
Data Collection.'' To achieve this Strategic Priority, CDRH established
a goal to assure the appropriate balance between premarket and
postmarket data
[[Page 52446]]
collection to facilitate and expedite the development and review of
medical devices, in particular high-risk devices of public health
importance. We established a target date of December 31, 2015, by which
to review 100 percent of product codes subject to a premarket approval
application (PMA) that are legally marketed and were approved prior to
2010 to determine, for each such product code, whether or not, based on
our current understanding of the technology, to reduce premarket data
collection by relying more on postmarket controls, and whether to shift
some premarket data collection to the postmarket setting or to pursue
down-classification.
DATES: Submit either electronic or written comments by October 7, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-1805 for ``Retrospective Review of Premarket Approval
Application Devices; Striking the Balance Between Premarket and
Postmarket Data Collection.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-796-5676.
SUPPLEMENTARY INFORMATION:
I. Background
One of three Strategic Priorities for 2014-2015 in CDRH is to
``Strike the Right Balance Between Premarket and Postmarket Data
Collection'' (Ref. 1).\1\ CDRH's vision is for patients in the United
States to have first-in-the-world access to high-quality, safe, and
effective medical devices of public health importance. A key
determinant of early U.S. patient access to high-quality, safe, and
effective devices is the extent of premarket data that device
developers provide to FDA. Once a device developer decides to seek U.S.
marketing approval or clearance, the extent of data that are collected
premarket has an impact upon the length of time needed to complete a
premarket submission--the more data to be collected premarket, the
longer it may take to acquire the data and make the submission.
Consequently, such data collection issues affect when U.S. patients
have access to a medical device. On the other hand, it is also
important that there are sufficient data to demonstrate a reasonable
assurance of safety and effectiveness before a device that is subject
to a premarket approval application (PMA) is approved for marketing in
the United States. For this reason, it is important that CDRH strike
the right balance between premarket and postmarket data collection. If
CDRH can shift, when appropriate, some premarket data collection to the
postmarket setting, CDRH could improve patient access to high-quality,
safe, and effective medical devices of public health importance.
However, patient safety could be undermined if, after determining that
certain data could appropriately be shifted from the premarket to the
postmarket setting, CDRH shifted that data collection to the postmarket
setting without adequate assurances that necessary and timely
postmarket data collection will occur. For this reason, CDRH strives to
balance the premarket data and postmarket collection, in accordance
with section 513(a)(3)(C) (21 U.S.C. 360c(a)(3)(C)) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), which directs CDRH to
consider whether the extent of data that otherwise would be required
for
[[Page 52447]]
approval of a PMA with respect to effectiveness can be reduced through
reliance on postmarket controls.
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\1\ CDRH's 2014-2015 Strategic Priorities include ``Strengthen
the Clinical Trial Enterprise'' and ``Provide Excellent Customer
Service'' in addition to ``Strike the Right Balance Between
Premarket and Postmarket Data Collection'' (Ref. 1).
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In order to achieve the proper balance between premarket and
postmarket data collection, CDRH resolved in its Strategic Priorities
for 2014-2015 to take several actions. CDRH committed to developing and
seeking public comment on a framework for when it would be appropriate
to shift premarket data collection to the postmarket setting. Pursuant
to this commitment, CDRH and the Center for Biologics Evaluation and
Research (CBER) issued the guidance, ``Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket Approval,''
on April 13, 2015 (80 FR 19672), which provided FDA's policy of
balancing premarket and postmarket data collection during the Agency's
review of PMAs (Ref. 2). This guidance outlines how FDA would consider
the role of postmarket information in determining the appropriate type
and amount of data that should be collected in the premarket setting to
support premarket approval, while still meeting the statutory standard
of a reasonable assurance of safety and effectiveness. Furthermore,
under existing authorities, CDRH and CBER issued a guidance document on
April 13, 2015 (80 FR 19669), entitled ``Expedited Access for Premarket
Approval Medical Devices Intended for Unmet Medical Need for Life
Threatening or Irreversibly Debilitating Diseases or Conditions'' (Ref.
3). This guidance describes FDA's voluntary expedited access PMA
program for certain medical devices to facilitate patient access to
these devices by expediting the development, assessment, and review of
certain devices that demonstrate the potential to address unmet medical
needs for life threatening or irreversibly debilitating diseases or
conditions. To expedite access for devices addressing unmet needs, this
pathway to market shifts appropriate components of premarket data
collection to the postmarket setting, while maintaining the statutory
standard of a reasonable assurance of safety and effectiveness. In
addition, CDRH has developed a mechanism to assure prospectively the
appropriate balance of premarket and postmarket data collection for new
devices subject to a PMA. Specifically, when CDRH issues a final
decision for an original PMA or panel-track supplement to a PMA, CDRH
conducts a prospective assessment to determine if the device type is a
candidate for shifting some premarket data collection to the
postmarket, reducing premarket data collection through reliance on
postmarket controls or reclassification.
Another action in pursuit of the goal to strike the right balance
between premarket and postmarket data collection was to commit to
conducting a retrospective review of all PMA product codes (procodes)
with active PMAs approved prior to 2010 to determine whether data
typically collected premarket could be shifted to the postmarket
setting, and whether premarket data collection could be reduced through
reliance on postmarket controls or devices could be reclassified (down-
classified) in light of our current understanding of the technology
(Ref. 1). In general, some premarket data collections for class III
devices that are currently marketed may be reduced through reliance on
postmarket controls or shifted to the postmarket setting if warranted,
based on CDRH's review experience as well as the postmarket performance
and the current body of evidence regarding the benefit-risk profile of
these devices. CDRH currently receives PMA submissions on the majority
of these class III devices, and a change in premarket data collection
is expected to expedite the approval of future PMA submissions. CDRH
has periodically taken such actions consistent with the medical device
statutory framework but has typically done so on an ad hoc basis. On
the other hand, when FDA determines that it is necessary to provide
reasonable assurance that a device is safe and effective, CDRH may
require more data based on our current understanding of that type of
technology or based on an issue raised by the data submitted by a
sponsor for their device. CDRH will also up-classify a device, if
warranted, based on the current state of the science. For example, on
January 5, 2016, CDRH issued a final order up-classifying surgical mesh
when intended for use for pelvic organ prolapse (81 FR 354), and on
June 2, 2014, CDRH issued a final order up-classifying sunlamps and
sunlamp products (tanning beds/booths) (79 FR 31205). However, up-
classification is not warranted for the devices subject to this
retrospective review, because they are already in the highest risk
classification.
During this retrospective review, devices were analyzed according
to procodes. CDRH targeted the date of December 31, 2014, by which to
review 50 percent of the procodes for devices that are subject to a PMA
and are legally marketed to determine whether or not to change
premarket data collection by shifting the data collection to the
postmarket setting, reducing premarket data collection through reliance
on postmarket controls, or pursuing reclassification (Ref. 1). This
target extended to have 75 percent completed by June 30, 2015, and 100
percent completed by December 31, 2015.
On April 29, 2015, CDRH announced its progress on this priority and
solicited comments on the procodes that were identified as candidates
for reclassification, a reduction in premarket data collection through
reliance on postmarket controls, or a shift in premarket data
collection to postmarket for those procodes reviewed through December
31, 2014 (80 FR 23798). FDA received 11 sets of comments, which
generally supported FDA's retrospective review effort and provided
input on specific procodes that were identified as candidates for
reclassification or were determined to remain class III with no changes
in data collection. FDA will consider these comments when making final
determinations on the reclassification of these procodes.
During 2015, FDA reviewed the remaining procodes that were
identified for the retrospective review. While completing the
retrospective review, FDA found that the LMX procode was included in
the retrospective review in error, because the jaundice meter device
type is covered by a different procode, not within the scope of the
retrospective review. The jaundice meter device type is classified
under 21 CFR 862.1113 and assigned the procode MQM, and accordingly,
this device type requires a 510(k) premarket notification. Therefore,
the procode LMX has been excluded from the analysis.
The purpose of this Federal Register notice is to solicit comments
on the remaining procodes that have been identified as candidates for
reclassification, a reduction in premarket data collection through
reliance on postmarket controls, or a shift in premarket data
collection to postmarket for those procodes reviewed through December
31, 2015. Efforts to reclassify and to communicate changes to data
collections with stakeholders will be prioritized based on both the
public health impact and Center resources.
II. Achievement of Goal Targets
Retrospective analysis of the class III medical device procodes was
intended to determine if current classifications and data collections
remain appropriate for determining a reasonable assurance of safety and
effectiveness. As our understanding of the technology associated with
individual medical devices has increased and we have a better
understanding of the risks
[[Page 52448]]
associated with the technology of each device, our understanding of the
type and amount of data that are needed to demonstrate a reasonable
assurance of safety and effectiveness also evolves. We use this
evolution in our understanding to require the least burdensome amount
of data necessary to evaluate device effectiveness, following the least
burdensome provisions of the FD&C Act (section 513(a)(3)(D)(ii)). Under
section 513 of the FD&C Act, a device is a class III device and
requires premarket approval if general controls and special controls
are insufficient to provide reasonable assurance of the safety and
effectiveness of the device, and if the device is to be used for
supporting or sustaining human life or of substantial importance in
preventing impairment of human health or if the device presents a
potential unreasonable risk of illness or injury. In order to
reclassify a class III device into class II, the device must meet the
statutory criteria for class II: A device that cannot be classified as
a class I device, because general controls are insufficient to provide
reasonable assurance of the safety and effectiveness of the device, and
for which there is sufficient information to establish special controls
to provide such assurance. As new information becomes available over
time, the accumulated information available for a device may be
sufficient to establish special controls to provide a reasonable
assurance of safety and effectiveness; therefore, the classification of
the device may be changed either up or down.
In February 2014, CDRH began its retrospective review with procodes
associated with active PMAs approved prior to 2010. PMA procodes
created since 2010 were not included in this retrospective review
because these recently created procodes do not yet have sufficient new
information for a change in FDA's current understanding of the device's
postmarket performance profile. As of December 31, 2015, CDRH reviewed
all procodes included in this retrospective review, meeting its 100
percent review target.
The results of this analysis include recommendations for procodes
that are candidates for reclassification, a reduction in premarket data
collection through reliance on postmarket controls, or a shift in
premarket data collection to postmarket collection. These results are
published online, along with the results of the first cohort of
procodes at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm
(Ref. 4). The results of this second cohort of procodes reviewed for
this analysis are additive to those previously reported. CDRH is
continuing to consider the comments received on the first cohort of
procodes reported in April 2015, and efforts to reclassify and to
communicate changes to data collections with stakeholders are being
prioritized based on both the public health impact and Center
resources. The following paragraph describes the organization of the
results into tables, which are available for public review online (Ref.
4).
As discussed in further detail below, for the purposes of this
retrospective review, we evaluated each procode on a balance of factors
to determine the current benefit-risk profile and if our review
indicates special controls could be established to provide a reasonable
assurance of safety and effectiveness. If so, the corresponding procode
was listed in the category ``Candidates for Reclassification to Class
II'' (table 1). If it was determined that special controls would not be
sufficient to provide reasonable assurance of the safety and
effectiveness of the device, then the procode was evaluated to
determine if some premarket data collection for PMA submission could be
shifted to postmarket collection, or if premarket data collection could
be reduced through reliance on postmarket controls. If it was
determined that a change of data collection could continue to provide
reasonable assurance of the safety and effectiveness of the device,
then the procode was listed in the category ``Candidates for reduction
of data collection through reliance on postmarket controls or shift of
data collection from premarket to postmarket'' (table 2). This category
includes procodes for which premarket data collection could be shifted
to postmarket data collection, premarket data collection could be
decreased through reliance on postmarket controls, or postmarket data
could no longer be needed. Finally, table 3 includes procodes for which
a reduction in data collection through reliance on postmarket controls
or shift in data collection from premarket to postmarket and/or
reclassification occurred in 2015 during FDA's retrospective review of
PMAs.
In this retrospective review, postmarket performance data,
technology and performance considerations, and other relevant
considerations were evaluated for each procode. These factors were used
to evaluate the current benefit-risk profile to determine if the
devices are good candidates for a reduction in premarket data
collection through reliance on postmarket controls, a shift of
premarket data collection to postmarket, or reclassification.
Postmarket performance data (including recent PMA Annual Reports,
literature reviews, total product lifecycle reports, medical device
reporting analysis, market penetration, and recall analysis) were
investigated for any performance concerns or problems that outpace any
increases in device use or acceptance. In evaluating the technology and
performance considerations for the procodes, performance concerns or
problems that were uncovered in the review of postmarket data were
considered unfavorable factors for a change in data collection or
reclassification. Favorable factors to indicate that a device is a good
candidate for a change in data collection or reclassification included:
Whether risks are now well understood and are determined to be moderate
to low; technology uncertainties have been alleviated; performance
standards or non-clinical tests have been developed that could be
surrogates for some clinical testing; the need for a controlled study
could be eliminated due to defined objective performance criteria; the
device has been shown to have good short-term performance; or concerns
are limited to long-term performance or rare adverse events.
Finally, several relevant considerations were evaluated for each
procode. Unfavorable factors for devices to be considered candidates
for a change in data collection or reclassification included: Whether
there have been significant changes implemented to address safety or
effectiveness since the devices have been on the market; whether the
review of annual reports and manufacturing changes has been important
to maintain safety of the devices; whether there were a limited number
of approvals or limited clinical use of the devices, due to inadequate
data needed to conduct this scientific assessment.
After completion of this retrospective review, FDA will prioritize
the procodes identified as candidates for reclassification (table 1,
Ref. 4) according to public health impact and Center resources, in
order to determine the top priority procodes for which reclassification
would have the greatest impact. The procodes identified as top priority
candidates for reclassification will proceed through the
reclassification procedures according to 21 CFR part 860. FDA will also
prioritize the procodes identified as candidates for a change in data
collection (table 2, Ref. 4) according to public health impact and
Center resources, in order to determine which reductions of or shifts
to data collection would have the greatest
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impact. FDA encourages firms to submit a presubmission to get feedback
on their data collection plan or contact the appropriate review branch
for additional information if they are in the process of developing a
device in one of these categories.
III. Paperwork Reduction Act of 1995
This document refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.
IV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.
1. FDA, ``CDRH 2014-2015 Strategic Priorities,'' 2014, http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM384576.pdf.
2. ``Guidance for Industry and FDA Staff: Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket
Approval,'' April 2015, http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393994.pdf.
3. ``Guidance for Industry and FDA Staff: Expedited Access for
Premarket Approval and De Novo Medical Devices Intended for Unmet
Medical Need for Life Threatening or Irreversibly Debilitating
Diseases or Conditions,'' April 2015, http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393978.pdf.
4. ``Second and final cohort of Results of the 2014-2015 Strategic
Priority: Strike the Right Balance between Premarket and Postmarket
Data Collection, '' available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18672 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P