Document ID: FDA-2010-N-0250-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Approval of Medical Devices
Posted Date: 2010-09-24T04:00Z

[Federal Register: September 24, 2010 (Volume 75, Number 185)]
[Notices]               
[Page 58396-58399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se10-85]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0250]

 
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.

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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 October 
25, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0231. 
Also include the FDA 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, 
Daniel.Gittleson@fda.hhs.gov.

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.

[[Page 58397]]

Premarket Approval of Medical Devices--21 CFR Part 814/Food and Drug 
Administration Modernization Act of 1997 (FDAMA) Sections 201, 202, 
205, 208, and 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 premarket 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 premarket 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 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 (premarket 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. 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 the 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 one PMA application 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.  
814.20.
    The industry-wide burden estimate for PMAs is based on an FDA 
actual average fiscal year (FY) annual rate of receipt of 36 PMA 
original applications, 532 PMA supplements, and 505 30-day notices 
using FY 2005 through 2009 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.
     Application in Sec.  814.20(a) through (c) and (e)
    The majority of the 24,048 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 36 
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 2005 through 2009. 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 manufacturers.
     Sec.  814.37--PMA Amendments and Resubmitted 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

[[Page 58398]]

amendments submitted during the review process. FDA estimates that 
6,012 burden hours are necessary to satisfy this requirement.
     PMA Supplements in Sec.  814.39(a)
    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 40,200 hours of burden are 
needed to complete the requirements for regular PMA supplements.
     Special PMA Supplements--Changes Being Affected in Sec.  
814.39(d)
    These types of supplements are 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 68 per year based on the 
numbers received from FY 2005 through FY 2009. 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 408 
hours.
     30-Day Notice in Sec.  814.39(f)
    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 Sec.  814.39(a) 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 8,080 hours.
     Post-Approval Requirements in Sec.  814.82(a)(9)
    Post-approval requirements concern 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 (18), 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 2,430 hours.
     Reports in Sec.  814.84(b)
    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 6,480 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 1,230 
hours. This burden estimate was based on actual real and estimated FDA 
data tracked from FY 2005 through FY 2009, and an estimate was also 
derived to forecast future expectations with regard to this statutory 
data.

Recordkeeping in Sec.  814.82(a)(5) and (a)(6)

    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, 70 percent of the PMAs are eventually approved with 90 
percent of these having original clinical trial data. Therefore, 
approximately 25 PMAs a year 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 698 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 698 holders of 
approved original PMAs, therefore, is 11,866 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.
    In the Federal Register of June 8, 2010 (75 FR 32476), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
            21 CFR Section/  FDAMA Section                 Respondents         per Response          Responses           Response         Total Hours
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814.15(b)                                                               8                     1                  8                  2                 16
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814.20                                                                 36                     1                 36                668             24,048
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814.37(a) through (c) and (e)                                          36                     1                 36                167              6,012
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814.39(a)                                                             670                     1                670                 60             40,200
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814.39(d)                                                              68                     1                 68                  6                408
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814.39(f)                                                             505                     1                505                 16              8,080
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[[Page 58399]]

814.82(a)(9)                                                           18                     1                 18                135              2,430
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814.84(b)                                                             648                     1                648                 10              6,480
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Section 201 (FDAMA) Agreement Meeting                                   3                     1                  3                 50                150
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Section 202 (FDAMA) Expedited Review Request                            5                     1                  5                 10                 50
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Section 205 (FDAMA) Effectiveness Meeting                               5                     1                  5                 50                250
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Section 208 (FDAMA) Classification Panel Meetings                      20                     1                 20                 30                600
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Section 209 (FDAMA) 100-day meeting                                    28                     1                 28                 10                280
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Totals                                                              2,050                    13              2,050              1,214             89,004
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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 Section                        Recordkeepers      per Recordkeeping        Records          Recordkeeper       Total Hours
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814.82(a)(5) and (a)(6)                                               698                     1                698                 17             11,866
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23912 Filed 9-23-10; 8:45 am]
BILLING CODE 4160-01-S