[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72063-72066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0825]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements for premarket 
approval of medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by December 19, 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'').

[[Page 72064]]

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-2013-N-0825 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Premarket Approval of Medical 
Devices'' 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Premarket Approval of Medical Devices--21 CFR part 814--OMB Control 
Number 0910-0231--Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360e) all devices placed into class III by FDA are 
subject to premarket approval requirements. Premarket approval (PMA) is 
the process of scientific and regulatory review to ensure the safety 
and effectiveness of class III devices. An approved PMA is, in effect, 
a private license granted to the applicant for marketing a particular 
medical device. A class III device that fails to meet PMA requirements 
is considered to be adulterated under section 501(f) of the FD&C Act 21 
U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements 
apply differently to preamendments devices, postamendments devices, and 
transitional class III devices.
    Manufacturers of class III preamendments devices, devices that were 
in commercial distribution before May 28, 1976, are not required to 
submit a PMA until 30 months after the issuance of a final 
classification regulation or until 90 days after the publication of a 
final regulation requiring the submission of a PMA, whichever period is 
later. FDA may allow more than 90 days after issuance of a final rule 
for submission of a PMA.
    A postamendments device is one that was first distributed 
commercially on or after May 28, 1976. Postamendments devices 
determined by FDA to be substantially equivalent to preamendments class 
III devices are subject to the same requirements as the preamendments 
devices. FDA determines substantial equivalence after reviewing an 
applicant's premarket notification submitted in accordance with section 
510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices 
determined by FDA to be not substantially equivalent to either 
preamendments devices or postamendments devices classified into class I 
or II are ``new'' devices and fall automatically into class III. Before 
such devices can be marketed, they must have an approved premarket 
approval application or be must reclassified into class I or class II.
    The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115) was enacted on November 21, 1997, to implement revisions to the 
FD&C Act by streamlining the process of bringing safe and effective 
drugs, medical devices, and other therapies to the U.S. market. FDAMA 
added section 515(d)(6) to the FD&C Act, which provided that PMA 
supplements were required for all device changes that affect safety and 
effectiveness unless such changes are modifications to manufacturing 
procedures or method of manufacture. That type of manufacturing change 
will require a 30-day notice, or where FDA

[[Page 72065]]

finds such notice inadequate, a 135-day PMA supplement.
    The implementing regulations, contained in part 814 (21 CFR part 
814), further specify the contents of a PMA for a medical device and 
the criteria FDA will employ in approving, denying, or withdrawing 
approval of a PMA and supplements to PMAs. The regulations' purpose is 
to establish an efficient and thorough procedure for FDA's review of 
PMAs and supplements to PMAs for class III medical devices. The 
regulations facilitate the approval of PMAs and supplements to PMAs for 
devices that have been shown to be reasonably safe and effective and 
otherwise meet the statutory criteria for approval. The regulations 
also ensure the denial of PMAs and supplements to PMAs for devices that 
have not been shown to be reasonably safe and effective and that do not 
otherwise meet the statutory criteria for approval.
    The industry-wide burden estimate for PMAs is based on an FDA 
average fiscal year (FY) annual rate of receipt of PMA submissions data 
FY 2013 through 2015 and our expectation of submissions to come in the 
next few years. The burden data for PMAs is based on data provided by 
applicants by device type and cost element in an earlier study.
    Reporting Burden: The reporting burden can be broken out by certain 
sections of the PMA regulations and the FD&C Act as follows:
    Sec.  814.15(b)--Research Conducted Outside the United States. Each 
foreign study should be performed in accordance with the ``Declaration 
of Helsinki'' or the laws and regulations of the country in which the 
study was conducted. If the study was conducted in accordance with the 
laws of the country, the PMA applicant is required to explain to FDA in 
detail the differences between the laws of the country and the 
``Declaration of Helsinki.'' Based on the number of PMAs received that 
contained studies from overseas, FDA estimates that the burden estimate 
necessary to meet this requirement is 50 hours.
    Sec.  814.20--Application. Included in this requirement are the 
conduct of laboratory and clinical trials as well as the analysis, 
review, and physical preparation of the PMA application. FDA estimates 
that 35 applicants, including hospital re-manufacturers of single-use 
devices, will be affected by these requirements which are based on the 
actual average of FDA receipt of new PMA applications in FY 2013 
through 2015. FDA's estimate of the hours per response (668) was 
derived through FDA's experience and consultation with industry and 
trade associations. In addition, FDA also based its estimate on the 
results of an earlier study that accounts for the bulk of the hourly 
burden for this requirement, which is identified by applicants.
    Sec.  814.37(a) through (c) and (e)--PMA Amendments and Resubmitted 
PMAs. As part of the review process, FDA often requests the PMA 
applicant to submit additional information regarding the device 
necessary for FDA to file the PMA or to complete its review and make a 
final decision. The PMA applicant may, also on their own initiative, 
submit additional information to FDA during the review process. These 
amendments contain information ranging from additional test results, 
re-analysis of the original data set, to revised device labeling. 
Almost all PMAs received by the Agency have amendments submitted during 
the review process.
    Sec.  814.39(a)--PMA Supplements. This information collection 
includes the requirements for the range of PMA supplements (panel 
track, 180-day fee-based, 180-day non-fee based, and real-time 
supplements).
    Sec.  814.39(d)--Special PMA Supplements--Changes Being Affected. 
This type of supplement is intended to enhance the safety of the device 
or the safe use of the device. The number of PMA supplements received 
that fit this category averaged 88 per year based on the numbers 
received from FY 2013 through FY 2015. Because of the minimal data 
required to be included in this type of supplement, FDA estimates that 
the burden hours necessary to satisfy this requirement are 528 hours.
    Sec.  814.39(f)--30-Day Notice. Under section 515(d) of the FD&C 
Act, modifications to manufacturing procedures or methods of 
manufacture that affect the safety and effectiveness of a device 
subject to an approved PMA do not require submission of a PMA 
supplement under paragraph (a) of this section and are eligible to be 
the subject of a 30-day notice. A 30-day notice shall describe in 
detail the change, summarize the data or information supporting the 
change, and state that the change has been made in accordance with the 
requirements of part 820 (21 CFR part 820). The applicant may 
distribute the device 30 days after the date on which FDA receives the 
30-day notice, unless FDA notifies the applicant within 30 days from 
receipt of the notice, that it is not adequate.
    Sec.  814.82(a)(9)--Postapproval Requirements. Postapproval 
requirements concerns approved PMAs that were not reclassified and 
require a periodic report. After approval, all PMAs require a 
submission of an annual report. A majority of the submitted PMAs 
require associated postapproval studies, i.e., followup of patients 
used in clinical trials to support the PMA or additional preclinical 
information that is labor-intensive to compile and complete; the 
remaining PMAs require minimal information.
    Sec.  814.84(b)--Periodic Reports. Postapproval requirements 
described in Sec.  814.82(a)(7) require submission of an annual report 
for each approved PMA. FDA estimates that respondents will average 
about 10 hours in preparing their reports to meet this requirement. 
This estimate is based on FDA's experience and consultation with 
industry.
    Expedited or Priority Review--Section 515(d)(5) of the FD&C Act. 
FDA will provide special review, which can include expedited processing 
of a PMA application, for certain devices intended to treat or diagnose 
life threatening or irreversibly debilitating diseases or conditions. 
To receive special review, the devices must meet one of the following 
criteria:
     The device represents a breakthrough technology;
     There are no approved alternatives;
     The use of the device offers significant advantages over 
existing approved alternatives;
     Availability is in the best interest of the patients.
    Agreement Meeting--Section 520(g)(7) of the FD&C Act (21 U.S.C. 
360j(g)(7)). Applicants planning to submit a PMA may submit a written 
request to reach agreement with FDA on the key parameters of the 
investigational plan.
    Determination Meeting--Section 513(a)(3)(D) of the FD&C Act (21 
U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a 
written request to FDA for a meeting to determine the type of 
information (valid scientific evidence) necessary to support the 
effectiveness of their device.
    Panel of Experts--Section 515(c)(3) of the FD&C Act. An original 
PMA or panel track PMA supplement is taken to an advisory panel of 
experts unless FDA determines that the information in the application 
substantially duplicates information which has previously been reviewed 
by the panel.
    Day 100 Meeting--Section 515(d)(3) of the FD&C Act. FDA must, upon 
the written request of the applicant, meet with that party within 100 
days of receipt of the filed PMA application to discuss the review 
status of the application. With the concurrence of the applicant, a 
different schedule may be established. Prior to this meeting, FDA must 
inform the applicant in writing of

[[Page 72066]]

any identified deficiencies and what information is required to correct 
those deficiencies. FDA must also promptly notify the applicant if FDA 
identifies additional deficiencies or of any additional information 
required to complete Agency review.

Recordkeeping

    Sec.  814.82(a)(5) and (a)(6)--Maintenance of Records. The 
recordkeeping burden under this section requires the maintenance of 
records, used to trace patients and the organization and indexing of 
records into identifiable files to ensure the device's continued safety 
and effectiveness. These records are required of all applicants who 
have an approved PMA.
    PMAs have been required since 1976, and there are 725 active PMAs 
that could be subject to these requirements, based on actual FDA data, 
and approximately 30 new PMAs are approved every year. The aggregate 
burden for the estimated 422 PMA holders of approved original PMAs for 
the next few years is estimated to be 7,174 hours.
    The applicant determines which records should be maintained during 
product development to document and/or substantiate the device's safety 
and effectiveness. Records required by the current good manufacturing 
practices for medical devices regulation (21 CFR part 820) may be 
relevant to a PMA review and may be submitted as part of an 
application. In individual instances, records may be required as 
conditions of approval to ensure the device's continuing safety and 
effectiveness.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
   Activity/21 CFR or FD&C Act       Number of    responses  per   Total annual   Average burden    Total hours
             section                respondents      respondent      responses     per response
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Research conducted outside the                25               1              25               2              50
 United States (814.15(b))......
PMA application (814.20)........              35               1              35             668          23,380
PMA amendments and resubmitted             1,222               1           1,222             167         204,074
 PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a)).....             695               1             695              60          41,700
Special PMA supplement--changes               88               1              88               6             528
 being affected (814.39(d)).....
30-day notice (814.39(f)).......           1,710               1           1,710              16          27,360
Postapproval requirements                    340               1             340             135          45,900
 (814.82(a)(9)).................
Periodic reports (814.84(b))....             695               1             695              10           6,950
Agreement meeting (520(g)(7))...               1               1               1              50              50
Expedited review request                       6               1               6              10              60
 (515(d)(5) of the FD&C Act)....
Determination Meeting                          1               1               1              50              50
 (513(1)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the                9               1               9              30             270
 FD&C Act)......................
Day 100 meeting (515(d)(3) of                 19               1              19              10             190
 the FD&C Act)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         350,562
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records  per     Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Maintenance of records (814.82(a)(5) and (a)(6))...................             422                1              422               17            7,174
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25232 Filed 10-18-16; 8:45 am]
 BILLING CODE 4164-01-P