[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Page 41505-41508]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0132]

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 August 
9, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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--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

[[Page 41506]]

manufacture and processing of the device; and labeling specimens.
    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 FDAMA affect the PMA process, such as section 515(d)(6) 
of the act. This section of the act 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.
    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 intable 
1 of this document, as part of the reporting burden in Sec.  814.15.
    In the Federal Register of April 5, 2004 (69 FR 17689), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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\
                                                                    Annual Frequency        Total Annual
              21 CFR Section                 No. of Respondents       per Response            Responses        Hours per Response        Total Hours
814.15, 814.20, and 814.37                          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
Total                                       ....................  ....................  ....................  ....................      95,189
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 41507]]

                                                   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 (a)(6)                          1,075                     1                 1,075                    17                18,275
Total                                       ....................  ....................  ....................  ....................      18,275
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 
     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 percent.

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.  814.3--PMA amendments and resubmitted PMAs
    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 
consultationwith 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 hours
    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 
    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 
postapproval 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 Sec.  814.82 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 in this document, 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 Sec.  
814.84 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 x 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 

[[Page 41508]]

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: July 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15662 Filed 7-8-04; 8:45 am]