[Federal Register: April 5, 2004 (Volume 69, Number 65)]
[Page 17689-17691]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0132]

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 information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for premarket approval of medical devices.

DATES: Submit written or electronic comments on the collection of 
information by June 4, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

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 listed below.
    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

    Section 515 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360e) sets forth the requirements for premarket approval of 
certain class III medical devices. Class III devices are either 
preamendments devices that have been classified into class III, 
postamendments devices which are not substantially equivalent to a 
preamendments device, or transitional devices. Class III devices are 
devices such as implants, life sustaining or life supporting devices, 
or devices which otherwise present a potentially unreasonable risk of 
illness or injury, or are of substantial importance in preventing 
impairment of human health. Most premarket approval application (PMAs) 
are for postamendments class III devices.
    Under section 515 of the act, an application must contain several 
pieces of information including full reports of all information 
concerning investigations showing whether the device is reasonably safe 
and effective. The application should also include a statement of 
components, ingredients, and properties and of the principle or 
principles of operation of such a device and should also include a full 
description of the methods used in, and the facilities and controls 
used for the manufacture and processing of the device; and labeling 
    The implementing regulations, contained in part 814 (21 CFR part 
814), further specify the contents of a PMA for a class III medical 
device and the criteria FDA employs in approving, denying, or 
withdrawing approval of a PMA and supplements to PMAs. The regulation's 
purpose is to establish an efficient and thorough procedure for FDA's 
review of PMAs and supplements to PMAs for certain class III (premarket 
approval) medical devices. The regulations contained in part 814 
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 disapproval 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 Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 
105-115) was enacted on November 21, 1997, to implement revisions to 
the act by streamlining the process of bringing safe and effective 
drugs, medical devices, and other therapies to the U.S. market. Several 
provisions of this act affect the PMA process, such as section 
515(d)(6) of the act. This section provided that PMA supplements were 
required for all device changes that affect safety and effectiveness of 
a device unless such changes are modifications to manufacturing 
procedures or method of manufacture. This type of manufacturing change 
requires a 30-day notice, or where FDA finds such notice inadequate, a 
135-day PMA supplement.
    To make the PMA process more efficient, in the past 3 years FDA has 
done the following: Made changes to the PMA program based on comments 
received, complied with changes to the program mandated by FDAMA, and 
worked towards completion of its PMA reinvention efforts.

[[Page 17690]]

    Respondents to this information collection are persons filing a PMA 
application or a PMA supplement with FDA for approval of certain class 
III medical devices. Part 814 defines a person as any individual, 
partnership, corporation, association, scientific or academic 
establishment, government agency or organizational unit, or other legal 
entity. These respondents include entities meeting the definition of 
manufacturers such as manufacturers of commercial medical devices in 
distribution prior to May 28, 1976 (the enactment date of the Medical 
Device Amendments). Additionally, hospitals that reuse single use 
devices (SUDs) are also included in the definition of manufacturers. It 
is expected that FDA will receive four PMA applications from hospitals 
that remanufacture SUDs annually. This figure has been included in 
table 1 of this document, as part of the reporting burden in Sec.  
    The total estimated reporting and recordkeeping burden for this 
information collection is 113,464 hours. FDA estimates the burden of 
this collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
  21 CFR Section/FDAMA                         Annual Frequency    Total Annual     Hours per
         Section          No. of Respondents     per Response        Responses      Response       Total Hours
814.15, 814.20, and              64                   1                  64           837            53,568
814.39(f)                       581                   1                 581            66            33,346
814.82                           45                   1                  45           135             6,075
814.84                           45                   1                  45            10               450
Section 201 (FDAMA)              10                   1                  10            10               100
Section 202 (FDAMA)              15                   1                  15            10               150
Section 205 (FDAMA)               8                   1                   8            50               400
Section 208 (FDAMA)              26                   1                  26            30               780
Section 209 (FDAMA)               8                   1                   8            40               320
Totals                    ..................  ..................  ..............  ............       95,189
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
                                                Annual Frequency of   Total Annual     Hours per
    21 CFR Section      No. of Recordkeepers       Recordkeeping         Records      Recordkeeper   Total Hours
814.82(a)(5) and             1,075                      1              1,075              17         18,275
Totals                 ......................  ....................  ..............  .............   18,275
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    The industry-wide burden estimate for PMAs is based on an FDA 
actual average fiscal year (FY) annual rate of receipt of 64 PMA 
original applications and 581 PMA supplements, using FY 1998 through 
2002 data.
    The burden data for PMAs is based on data provided by manufacturers 
by device type and cost element in an earlier study. The specific 
burden elements for which FDA has data are as follows:
     Clinical investigations: 67 percent of total 
burden estimate;
     Submission of additional data or information to 
FDA during a PMA review: 12 percent;
     Additional device development cost (e.g., 
testing): 10 percent; and
     PMA and PMA supplement preparation and 
submissions, and development of manufacturing and controls data: 11 

Paperwork Burden Estimate

    The burden estimates were derived by consultation with FDA and 
industry personnel. FDA's estimates are based on actual data collected 
from industry over the past 3 years. An evaluation of the type and 
scope of information requested was also used to derive some time 
estimates. For example, disclosure information primarily requires time 
only to update and maintain existing manuals.


    The reporting burden can be broken out by certain sections of the 
PMA regulation as follows:
     Sec.  814.15--Research conducted outside the 
United States
     Sec.  814.20 --Application
     Sec.  814.37--PMA amendments and resubmitted 
    The majority of the burden--53,568 burden hours--is due to the 
previously listed three requirements. Included in these three 
requirements are the conduct of laboratory and clinical trials as well 
as the analysis, review, and physical preparation of the PMA 
application. FDA estimates that 64 manufacturers (including hospital 
remanufacturers of single use devices) will be affected by these 
requirements based on actual average FDA receipt of new PMA 
applications in FY 1998 through 2002. FDA's estimate of the hours per 
response (837) was derived through FDA's experience and consultation 
with industry and trade associations. Included in these three 
requirements are the conduct of laboratory and clinical trails as well 
as the analysis, review, and physical preparation of the PMA 
application. In addition, FDA has based its estimate on the results of 
an earlier study that these requirements account for the bulk of the 
burden identified by manufacturers.
     Sec.  814.39 (f)--PMA supplements: 33,346 burden 
    FDA believes that the amendments mandated by FDAMA for Sec.  
814.39(f), permitting the submission of the 30-day notices in lieu of 
regular PMA supplements, will result in an approximate 10 percent 
reduction in the total number of hours as compared to regular PMA 
supplements. As a result, FDA estimates that 33,346 hours of burden are 
needed to complete the requirements for regular PMA supplements.
     Sec.  814.82--Postapproval requirements: 6,075 
burden hours
    Postapproval requirements concern approved PMAs that were not 
reclassified and require a periodic report. The range of PMAs that fit 
this category averaged approximately 45 per year (70 percent of the 64 
periodic submissions). Most approved PMAs have been subject to some 
post approval

[[Page 17691]]

study requirement. Approximately half of the average submitted PMAs 
(32) 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, and the other PMAs require minimal information. Based on 
experience and consultation with industry, FDA has estimated that 
preparation of reports and information required by this section require 
6,075 hours (135 hours per respondent).
     Sec.  814.84--Reports: 450 burden hours
    Postapproval requirements described in Sec.  814.82 require a 
periodic report. FDA has determined respondents meeting the criteria of 
Sec.  814.84 will submit reports on a periodic basis. As stated 
previously, the range of PMAs fitting this category averaged 
approximately 45 per year. These reports have minimal information 
requirements. FDA estimates that respondents will construct their 
report and meet their requirements in approximately 10 hours. This 
estimate is based on FDA's experience and on consultation with 
industry. FDA estimates that the periodic reporting required by this 
section will take 450 hours.
    Statutory Burden: The total hours for statutory burden is 1,750. 
This burden estimate was based on actual real FDA data tracked from 
January 1, 1998, to the present, and an estimate was derived to 
forecast future expectations with regard to this statutory data.


    The recordkeeping burden in this section involves 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 would be required only of those 
manufacturers who have an approved PMA and who had original clinical 
research in support of that PMA. For a typical year's submissions, 70 
percent of the PMAs are eventually approved and 75 percent of those 
have original clinical trial data. Therefore, approximately 45 PMAs a 
year (64 annual submissions times 70 percent) would be subject to these 
requirements. Also, because the requirements apply to all active PMAs, 
all holders of active PMA applications must maintain these records. 
PMAs have been required since 1976, and there are 1,075 active PMAs 
that could be subject to these requirements, based on actual FDA data. 
Each study has approximately 200 subjects, and at an average of 5 
minutes per subject, there is a total burden per study of 1,000 
minutes, or 17 hours. The aggregate burden for all 1,075 holders of 
approved original PMAs, therefore, is 18,275 hours (1,075 approved PMAs 
with clinical data x 17 hours per PMA).
    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 to approval to ensure the device's continuing safety and 

    Dated: March 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7607 Filed 4-2-04; 8:45 am]