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

FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-796-5676.

SUPPLEMENTARY INFORMATION:

I. Background

    One of three Strategic Priorities for 2014-2015 in CDRH is to 
``Strike the Right Balance Between Premarket and Postmarket Data 
Collection'' (Ref. 1).\1\ CDRH's vision is for patients in the United 
States to have first in the world access to high-quality, safe, and 
effective medical devices of public health importance. A key 
determinant of early U.S. patient access to high-quality, safe, and 
effective devices is the extent of premarket data that device 
developers provide to FDA. Once a device developer decides to seek U.S. 
marketing approval or clearance, the extent of data that is collected 
premarket has an impact upon the length of time needed to complete a 
premarket submission--the more data to be collected premarket, the 
longer it may take to acquire the data and make the submission. 
Consequently, such data collection issues affect when U.S. patients 
have access to a medical device. On the other hand, it is also 
important that there is sufficient data to demonstrate a reasonable 
assurance of safety and effectiveness before a device subject to a 
premarket approval application (PMA) is approved for marketing in the 
United States. For this reason, it is important that CDRH strike the 
right balance between premarket and postmarket data collection. If CDRH 
can shift--when appropriate--some premarket data collection to the 
postmarket setting, CDRH could improve patient access to high-quality, 
safe, and effective medical devices of public health importance. 
However, patient safety could be undermined if CDRH shifted some data 
collection from the premarket to the postmarket setting without 
adequate assurances that necessary and timely data collection will 
occur. For this reason, CDRH strives to balance the premarket data and 
postmarket collection, in accordance with section 513(a)(3)(C) (21 
U.S.C. 360c(a)(3)(C)) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act), which directs CDRH to consider whether the extent of data 
that otherwise would be required for approval of a PMA with respect to 
effectiveness can be reduced through reliance on postmarket controls.
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    \1\ CDRH's 2014-2015 Strategic Priorities include ``Strengthen 
the Clinical Trial Enterprise'' and ``Provide Excellent Customer 
Service,'' in addition to ``Strike the Right Balance Between 
Premarket and Postmarket Data Collection'' (Ref. 1).

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[[Page 23799]]

    In order to achieve the proper balance between premarket and 
postmarket data collection, CDRH resolved in its Strategic Priorities 
for 2014-2015 to take several actions. CDRH committed to developing and 
seeking public comment on a framework for when it would be appropriate 
to shift premarket data collection to the postmarket setting. Pursuant 
to this commitment, CDRH and the Center for Biologics Evaluation and 
Research (CBER) issued the draft guidance, ``Balancing Premarket and 
Postmarket Data Collection for Devices Subject to Premarket Approval'' 
on April 23, 2014 (78 FR 22690). This draft guidance proposed an FDA 
policy of balancing premarket and postmarket data collection during the 
Agency's review of PMAs. This guidance outlined how FDA would consider 
the role of postmarket information in determining the appropriate type 
and amount of data that should be collected in the premarket setting to 
support premarket approval, while still meeting the statutory standard 
of a reasonable assurance of safety and effectiveness. Comments on this 
draft guidance were collected through July 22, 2014, and the guidance 
was finalized on April 13, 2015 (Ref. 2). Furthermore, under existing 
authorities, CDRH and CBER issued a draft guidance document on April 
23, 2014 (78 FR 22691), entitled ``Expedited Access for Premarket 
Approval Medical Devices Intended for Unmet Medical Need for Life 
Threatening or Irreversibly Debilitating Diseases or Conditions.'' This 
draft guidance described FDA's proposal for a new, voluntary expedited 
access PMA program for certain medical devices to facilitate patient 
access to these devices by expediting the development, assessment, and 
review of certain devices that demonstrate the potential to address 
unmet medical needs for life threatening or irreversibly debilitating 
diseases or conditions. To expedite access for devices addressing unmet 
needs, this pathway to market would shift appropriate premarket data 
collection to the postmarket setting while maintaining the statutory 
standard of a reasonable assurance of safety and effectiveness. 
Comments on this draft guidance were collected through July 22, 2014, 
and the guidance was finalized and issued on April 13, 2015 (Ref. 3). 
In addition, CDRH is currently developing a mechanism to prospectively 
assure the appropriate balance of premarket and postmarket data 
collection for new devices subject to a PMA.
    Another action in pursuit of the goal to strike the right balance 
between premarket and postmarket data collection is to commit to 
conducting a retrospective review of all PMA product codes (procodes) 
with active PMAs approved prior to 2010 to determine whether data 
typically collected premarket could be shifted to the postmarket 
setting, premarket data collection could be reduced through reliance on 
postmarket controls, or devices could be reclassified (down-classified) 
in light of our current understanding of the technology (Ref. 1). In 
general, some premarket data collections for class III devices that are 
currently marketed may be reduced through reliance on postmarket 
controls, or shifted to the postmarket setting if warranted based on 
CDRH's review experience as well as the postmarket performance and the 
current body of evidence regarding the benefit-risk profile of these 
devices. CDRH currently receives PMA submissions on the majority of 
these class III devices, and a change in premarket data collection is 
expected to expedite the approval of future PMA submissions. CDRH has 
periodically taken such actions consistent with the medical device 
statutory framework but has typically done so on an ad hoc basis. On 
the other hand, CDRH routinely requires more data when warranted based 
on our current understanding of that type of technology or based on 
issued raised by the data submitted by a sponsor for their device. CDRH 
will also up-classify a device, if warranted, based on the current 
state of the science. For example, in May 2014, CDRH proposed to up-
classify surgical mesh when intended for use for pelvic organ prolapse 
(79 FR 24634), and in June 2014, CDRH issued a final order up-
classifying sunlamps and sunlamp products (tanning beds/booths) (79 FR 
31205). However, up-classification is not warranted for the devices 
subject to this retrospective review, because they are already in the 
highest risk classification.
    During this retrospective review, the devices are analyzed 
according to procode. CDRH targeted the date of December 31, 2014, to 
review 50 percent of procodes subject to a PMA that are legally 
marketed to determine whether or not to change premarket data 
collection by shifting to the postmarket setting, reducing premarket 
data collection through reliance on postmarket controls, or pursuing 
reclassification (Ref. 1). This target extends to have 75 percent 
completed by June 30, 2015, and 100 percent completed by December 31, 
2015.
    The purpose of this Federal Register notice is to solicit comments 
on the procodes that have been identified as candidates for 
reclassification, a reduction in premarket data collection through 
reliance on postmarket controls, or a shift in premarket data 
collection to postmarket for those procodes reviewed through December 
31, 2014. Efforts to reclassify and to communicate changes to data 
collections with stakeholders will be prioritized based on both the 
public health impact and Center resources.

II. Progress Toward Goal Targets

    Retrospective analysis of the class III medical device procodes is 
intended to determine if current classifications and data collections 
remain appropriate for determining a reasonable assurance of safety and 
effectiveness. As our understanding of the technology associated with 
individual medical devices has increased and we have a better 
understanding of the risks associated with the technology of each 
device, the type and amount of data that is needed to demonstrate a 
reasonable assurance of safety and effectiveness evolve. This evolution 
to require the least burdensome amount of data to evaluate device 
effectiveness follows the least burdensome provisions of the FD&C Act 
(section 513(a)(3)(D)(ii)). Under section 513 of the FD&C Act, a device 
is a class III device and requires premarket approval if general 
controls and special controls are insufficient to provide reasonable 
assurance of the safety and effectiveness of the device, and if the 
device is to be used for supporting or sustaining human life or of 
substantial importance in preventing impairment of human health or if 
the device presents a potential unreasonable risk of illness or injury. 
In order to reclassify a class III device into class II, the device 
must meet the statutory criteria for class II: A device which cannot be 
classified as a class I device, because general controls are 
insufficient to provide reasonable assurance of the safety and 
effectiveness of the device, and for which there is sufficient 
information to establish special controls to provide such assurance. As 
new information becomes available over time, the accumulated 
information available for a device may be sufficient to establish 
special controls to provide a reasonable assurance of safety and 
effectiveness; therefore, the classification of the device may be 
changed either up or down.
    In February 2014, CDRH began its retrospective review with procodes 
associated with active PMAs approved prior to 2010. PMA procodes 
created since 2010 were not included in this retrospective review 
because these

[[Page 23800]]

recently created procodes do not yet have sufficient new information 
for a change in FDA's current understanding of the device's postmarket 
performance profile. As of December 31, 2014, CDRH reviewed 69 percent 
of the procodes included in this retrospective review, exceeding its 50 
percent review target.
    The results of this analysis include recommendations for procodes 
that are candidates for reclassification, a reduction in premarket data 
collection through reliance on postmarket controls, or a shift in 
premarket data collection to postmarket collection. These results are 
published online at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm. As discussed in further detail, for the purposes of this 
retrospective review, we evaluated each procode on a balance of factors 
to determine the current benefit-risk profile and if our review 
indicates special controls could be established to provide a reasonable 
assurance of safety and effectiveness. If so, the corresponding procode 
was listed in the category ``Candidates for Reclassification to Class 
II'' (Table 1). If it was determined that special controls would not be 
sufficient to provide reasonable assurance of the safety and 
effectiveness of the device, then the procode was evaluated to 
determine if some premarket data collection for PMA submission could be 
shifted to postmarket collection, or if premarket data collection could 
be reduced through reliance on postmarket controls. If it was 
determined that a change of data collection could continue to provide 
reasonable assurance of the safety and effectiveness of the device, 
then the procode was listed in the category ``Candidates for reduction 
of data collection through reliance on postmarket controls or shift of 
data collection from premarket to postmarket'' (Table 2). This category 
includes procodes for which premarket data collection could be shifted 
to postmarket data collection, premarket data collection could be 
decreased through reliance on postmarket controls, or postmarket data 
could no longer be needed. Finally, Table 3 includes procodes for which 
a reduction in data collection through reliance on postmarket controls 
or shift in data collection from premarket to postmarket and/or 
reclassification occurred in 2014, during FDA's retrospective review of 
PMAs.
    In this retrospective review, postmarket performance data, 
technology and performance considerations, and other relevant 
considerations were evaluated for each procode. These factors were used 
to evaluate the current benefit-risk profile to determine if the 
devices are good candidates for a reduction in premarket data 
collection through reliance on postmarket controls, a shift of 
premarket data collection to postmarket, or reclassification. 
Postmarket performance data (including recent PMA Annual Reports, 
literature reviews, total product lifecycle reports, medical device 
reporting analysis, market penetration, and recall analysis) were 
investigated for any performance concerns or problems that outpace any 
increases in device use or acceptance. In evaluating the technology and 
performance considerations for the procodes, performance concerns or 
problems that were uncovered in the review of postmarket data were 
considered unfavorable factors for a change in data collection or 
reclassification. Favorable factors to indicate a device is a good 
candidate for a change in data collection or reclassification included 
if risks are now well understood and determined to be moderate to low, 
technology uncertainties have been alleviated, performance standards or 
non-clinical tests have been developed that could be surrogates for 
some clinical testing, the need for a controlled study could be 
eliminated due to defined objective performance criteria, the device 
has been shown to have good short-term performance, or concerns are 
limited to long-term performance or rare adverse events.
    Finally, several relevant considerations were evaluated for each 
procode. Unfavorable factors for devices to be considered candidates 
for a change in data collection or reclassification included if there 
have been significant changes implemented to address safety or 
effectiveness since the devices have been on the market or if the 
review of annual reports and manufacturing changes has been important 
to maintain safety of the devices. Furthermore, if there were a limited 
number of approvals or limited clinical use of the devices, this was 
considered an additional unfavorable factor for the devices to be 
considered candidates for a change in data collection or 
reclassification, due to inadequate data needed to conduct this 
scientific assessment.
    After completion of this retrospective review, FDA will prioritize 
the procodes identified as candidates for reclassification (Table 1) 
according to public health impact and Center resources, in order to 
determine the top priority procodes for which reclassification would 
have the greatest impact. The procodes identified as top priority 
candidates for reclassification will proceed through the 
reclassification procedures according to 21 CFR part 860. FDA will also 
prioritize the procodes identified as candidates for a change in data 
collection (Table 2) according to public health impact and Center 
resources, in order to determine which reductions of or shifts to data 
collection would have the greatest impact. The FDA encourages firms to 
submit a presubmission to get feedback on their data collection plan or 
contact the appropriate review branch for additional information if 
they are in the process of developing a device in one of these 
categories.

III. Paperwork Reduction Act of 1995

    This document refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

IV. Comments

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

V. References

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

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

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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 http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393994.pdf.
3. ``Guidance for Industry and FDA Staff: Expedited Access for 
Premarket Approval and De Novo Medical Devices Intended for Unmet 
Medical Need for Life Threatening or Irreversibly Debilitating 
Diseases or Conditions,'' April 2015, available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm393978.pdf.

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