[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44128-44130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17549]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 September 23, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[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 and Federal 
Food, Drug, and Cosmetic Act Sections 513, 515, and 520 (OMB Control 
Number 0910-0231)--Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360(e)) 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. 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) (Public Law 
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 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.

[[Page 44129]]

    The industry-wide burden estimate for PMAs is based on an FDA 
actual average fiscal year (FY) annual rate of receipt of PMA 
submissions data FY 2010 through 2012 and our expectations 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 40 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 2010 through 2012. 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 which 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 Re-Submitted 
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. FDA 
estimates that 20,040 burden hours are necessary to satisfy this 
requirement.

Sec.  814.39(a)--PMA Supplements

    FDA believes that 39,000 burden hours are needed to complete the 
requirements for the range of PMA supplements (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 supplements 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 80 per year based on the 
numbers received from FY 2010 through FY 2012. 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 480 
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. FDA 
estimates the burden to satisfy this requirement is 24,000 hours.

Sec.  814.82(a)(9)--Post-Approval Requirements

    Post-approval 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. Based on 
experience and consultation with industry, FDA has estimated that 
preparation of reports and information required by this section 
requires 31,050 hours.

Sec.  814.84(b)--Periodic Reports

    Post-approval 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. Thus, FDA estimates that the periodic 
reporting burden required by this section will take 6,000 hours.

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, or
     Availability is in the best interest of the patients.

Agreement Meeting--Section 520(g)(7) of the FD&C Act

    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

    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

[[Page 44130]]

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.
    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 556 active PMAs 
that could be subject to these requirements, based on actual FDA data, 
and approximately 25 new PMAs are approved every year. The aggregate 
burden for the estimated 600 PMA holders of approved original PMAs for 
the next few years is estimated to be 10,200 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 (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\
----------------------------------------------------------------------------------------------------------------
                                                     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)........              40               1              40             668          26,720
PMA amendments and resubmitted               120               1             120             167          20,040
 PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a)).....             650               1             650              60          39,000
Special PMA supplement--changes               80               1              80               6             480
 being affected (814.39(d)).....
30-day notice (814.39(f)).......           1,500               1           1,500              16          24,000
Postapproval requirements                    230               1             230             135          31,050
 (814.82(a)(9)).................
Periodic reports (814.84(b))....             600               1             600              10           6,000
Agreement meeting (520(g)(7))...               3               1               3              50             150
Expedited review request                       5               1               5              10              50
 (515(d)(5) of the FD&C Act)....
Determination Meeting                          5               1               5              50             250
 (513(1)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the               10               1              10              30             300
 FD&C Act)......................
Day 100 meeting (515(d)(3) of                 10               1              10              10             100
 the FD&C Act)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         148,190
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                    Table 2--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (a)(6))...................             600                1              600               17           10,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17549 Filed 7-22-13; 8:45 am]
BILLING CODE 4160-01-P