[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Notices]
[Page 41505-41508]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy04-96]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
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 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.
Reporting/Disclosure
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
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
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.
Recordkeeping
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
approved
[[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
effectiveness.
Dated: July 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15662 Filed 7-8-04; 8:45 am]
BILLING CODE 4160-01-S