[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

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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

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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