[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35494-35497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12502]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0231]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pre-market Approval of Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 information collection
requirements for premarket approval of medical devices.
DATES: Submit written or electronic comments on the collection of
information by August 27, 2007.
ADDRESSES: Submit electronic comments on the collection of information
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: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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.
Pre-market Approval of Medical Devices--21 CFR Part 814 / FDAMA
Sections 201; 202; 205; 208; 209 (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 pre-market approval of
certain class III medical devices. Class III devices are either pre-
amendments devices that have been classified into class III, or post-
amendments devices which are not substantially equivalent to a pre-
amendments device, or transitional devices. Class III devices are
devices such as implants, life sustaining or life supporting devices,
and /or devices which otherwise present a potentially unreasonable risk
of illness or injury, and /or are of substantial importance in
preventing impairment of human health. Most pre-market approval
applications (PMAs) are for post-amendments class III devices.
Under section 515 of the act, an application must contain certain
specific 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 of the principles of operation
for such a device. In addition, the application 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 specimens. The implementing regulations, contained in
[[Page 35495]]
part 814 (21 CFR part 814), further specifies the contents of a PMA for
a class III medical device and the criteria FDA sets forth in
approving, denying, or withdrawing approval of a PMA as well as
supplements to PMAs. The purpose of this regulation is to establish an
efficient and thorough procedure for FDA's review of PMAs and
supplements to PMAs for certain class III (pre-market approval) medical
devices. The regulations under 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
now 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 several years
FDA has done the following: (1) Made changes to the PMA program based
on comments received; (2) complied with changes to the program mandated
by FDAMA and Medical Device User Fee Modernization Act; and (3) worked
toward 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). In addition, 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.
814.15.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR Part 800/ Section/ No. of Annual Frequency Total Annual Hours Per
FDAMA Respondents per Response Responses Responses Total Hours
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814.15(b) 10 1 10 2 20
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814.20 48 1 48 668 32,064
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814.37(a-c) and (e) 48 1 48 167 8,016
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814.39(a) 460 1 460 60 27,600
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814.39(d) 70 1 70 6 420
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814.39(f) 254 1 254 16 4,064
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814.82(a)(9) 34 1 34 135 4,590
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814.84(b) 34 1 34 10 340
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Section 201 (FDAMA) Agreement 3 1 3 50 150
Meeting
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Section 202 (FDAMA) Expedited 7 1 7 10 70
Reviews
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Section 205 (FDAMA) 5 1 5 50 250
Determination Meeting
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Section 208 (FDAMA) 19 1 19 30 570
Classification Panel
Meetings
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Section 209 (FDAMA) 100 day 36 1 36 10 360
meeting
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Totals 1,028 13 1,028 1,214 78,514
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Part 800 Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
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842 (a) (5) & (6) 1,128 1 1,128 17 19,176
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 35496]]
The industry-wide burden estimate for PMAs is based on an FDA
actual average fiscal year (FY) annual rate of receipt of 48 PMA
original applications, 530 PMA supplements, and 254 30-day notices
using FY 2002 through 2006 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.
Reporting Burden:
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
Approximately 20 percent of the clinical studies submitted in
support of a PMA application are conducted outside the United States.
Each 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 20 hours.
Sec. 814.20 (a) through (c) and (e)--Application
The majority of the 32,064 hourly burden estimate is due in part to
this requirement. 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 48
manufacturers, including hospital re-manufacturers of SUDs, will be
affected by these requirements which are based on the actual average of
FDA receipt of new PMA applications in FY 2002 through 2006. 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, identified by manufacturers.
Sec. 814.37--PMA Amendments and Re-Submitted PMAs
As part of the review process, FDA often requests 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 8,016 burden hours are necessary to satisfy this
requirement.
Sec. 814.39 (a)--PMA Supplements
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 20 percent
reduction in the total number of hours as compared to regular PMA
supplements. As a result, FDA estimates that 27,600 hours of burden are
needed to complete the requirements for regular PMA 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 70 per year based on the
numbers received from FY 2002 through FY 2006. 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 420
hours.
Sec. 814.39(f)--30-Day Notice
Under section 515(d) of the 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
manufacturer 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 4,064 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. On average, approximately
half of the submitted PMAs (34), require associated post-approval
studies, i.e., follow-up 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 4,590 hours.
Sec. 814.84(b)--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 340 hours.
Statutory Reporting Burden Estimate (FDAMA)
The total statutory reporting burden under the requirements of
sections 201, 202, 205, 208, and 209 of FDAMA is estimated to be 1,400
hours. This burden estimate was based on actual real FDA data tracked
from January 1, 1998, to the present, and an estimate was also derived
to forecast future expectations with regard to this statutory data.
Sec. 814.82 (a) (5) and (a)(6)--Recordkeeping
The recordkeeping burden under this section requires the
maintenance of records, used to trace patients and the organization and
the indexing of records into identifiable files to ensure the device's
continued safety and effectiveness. These records are 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,
[[Page 35497]]
70 percent of the PMAs are eventually approved with 75 percent of these
having original clinical trial data. Therefore, approximately 34 PMAs a
year (48 annual submissions x 70 percent), would be subject to these
requirements. Also, because the requirements apply to all active PMAs,
all holders of an active PMA application must maintain these records.
PMAs have been required since 1976, and there are 1,128 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 1,128 holders of
approved original PMAs, therefore, is 19,176 hours (1,127 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 (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.
Dated: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12502 Filed 6-27-07; 8:45 am]
BILLING CODE 4160-01-S