[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Pages 7839-7841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01188]



Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Premarket Approval of 
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 22, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0231. 
Also include the FDA docket number found in brackets in the heading of 
this document.

Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Premarket Approval of Medical Devices--OMB Control Number 0910-0231--

    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 (PMA) requirements. 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. PMA 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 PMA 
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 (21 U.S.C. 360e(d)(6)), 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 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 
FYs 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

[[Page 7840]]

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 is 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 remanufacturers 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 FYs 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 and 
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 
    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 FYs 2013 through 2015. Because of the minimal data 
required to be included in this type of supplement, FDA estimates that 
the number of burden hours necessary to satisfy this requirement is 
    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 post-approval 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 
    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 
     The device represents a breakthrough technology;
     There are no approved alternatives;
     The use of the device offers significant advantages over 
existing approved alternatives; or
     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 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.


    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

[[Page 7841]]

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.
    In the Federal Register of October 19, 2016 (81 FR 72063), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                 Table 1--Estimated Annual Reporting Burden \1\
                                                     Number of                        Average
   Activity/21 CFR or FD&C Act       Number of     responses per   Total annual     burden per      Total hours
             section                respondents     respondent       responses       response
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
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
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

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

    Dated: January 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01188 Filed 1-19-17; 8:45 am]