[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32476-32479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13763]



-----------------------------------------------------------------------



DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



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




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 collection of 

information, and to allow 60 days for public comment in response to the 

notice. This notice solicits comments on requirements for premarket 

approval of medical devices.



DATES:  Submit either electronic or written comments on the collection 

of information by August 9, 2010.



[[Page 32477]]





ADDRESSES: Submit electronic comments on the collection of information 

to http://www.regulations.gov. 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: 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: 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.



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.

    FDA estimates the burden of this collection of information as 

follows:



                                                     Table 1.--Estimated Annual Reporting Burden\1\

--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                              No. of         Annual Frequency       Total Annual        Hours per

            21 CFR Section/  FDAMA Section                 Respondents         per Response          Responses           Response         Total Hours

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.15(b)                                                               8                     1                  8                  2                 16

--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 32478]]



 

814.20                                                                 36                     1                 36                668             24,048

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.37(a) through (c) and (e)                                          36                     1                 36                167              6,012

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.39(a)                                                             670                     1                670                 60             40,200

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.39(d)                                                              68                     1                 68                  6                408

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.39(f)                                                             505                     1                505                 16              8,080

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.82(a)(9)                                                           18                     1                 18                135              2,430

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.84(b)                                                             648                     1                648                 10              6,480

--------------------------------------------------------------------------------------------------------------------------------------------------------

Section 201 (FDAMA) Agreement Meeting                                   3                     1                  3                 50                150

--------------------------------------------------------------------------------------------------------------------------------------------------------

Section 202 (FDAMA) Expedited Review Request                            5                     1                  5                 10                 50

--------------------------------------------------------------------------------------------------------------------------------------------------------

Section 205 (FDAMA) Effectiveness Meeting                               5                     1                  5                 50                250

--------------------------------------------------------------------------------------------------------------------------------------------------------

Section 208 (FDAMA) Classification Panel Meetings                      20                     1                 20                 30                600

--------------------------------------------------------------------------------------------------------------------------------------------------------

Section 209 (FDAMA) 100-day meeting                                    28                     1                 28                 10                280

--------------------------------------------------------------------------------------------------------------------------------------------------------

Totals                                                              2,050                    13              2,050              1,214             89,004

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.





                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\

--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                              No. of         Annual Frequency       Total Annual        Hours per

                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records          Recordkeeper       Total Hours

--------------------------------------------------------------------------------------------------------------------------------------------------------

814.82(a)(5) and (a)(6)                                               698                     1                698                 17             11,866

--------------------------------------------------------------------------------------------------------------------------------------------------------

\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 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 PMA applicant to 

submit



[[Page 32479]]



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 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.



    Dated: June 2, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-13763 Filed 6-7-10; 8:45 am]

BILLING CODE 4160-01-S