
[Federal Register: June 24, 2010 (Volume 75, Number 121)]
[Notices]               
[Page 36092-36097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn10-48]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0273]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices: Current Good Manufacturing Practice 
Quality System Regulations

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

[[Page 36093]]

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 recordkeeping requirements 
related to the medical devices current good manufacturing practice 
(CGMP) quality system (QS) regulation (CGMP/QS regulation).

DATES: Submit either electronic or written comments on the collection 
of information by August 23, 2010.

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 20857, 301-796-5156 email: 
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.

Medical Devices: Current Good Manufacturing Practice Quality System 
Regulations--21 CFR Part 820 (OMB Control Number 0910-0073)--Extension

    Under section 520(f) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360j(f)), the Secretary of the Department of 
Health and Human Services has the authority to prescribe regulations 
requiring that the methods used in, and the facilities and controls 
used for, the manufacture, pre-production design validation (including 
a process to assess the performance of a device but not including an 
evaluation of the safety and effectiveness of a device), packing, 
storage, and installation of a device conform to CGMP, as described in 
such regulations, to assure that the device will be safe and effective 
and otherwise in compliance with the act.
    The CGMP/QS regulation implementing authority provided by this 
statutory provision is found under part 820 (21 CFR part 820) and sets 
forth basic CGMP requirements governing the design, manufacture, 
packing, labeling, storage, installation, and servicing of all finished 
medical devices intended for human use. The authority for this 
regulation is covered under sections 501, 502, 510, 513, 514, 515, 518, 
519, 520, 522, 701, 704, 801, and 803 of the act (21 U.S.C. 351, 352, 
360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and 383). 
The CGMP/QS regulation includes requirements for purchasing and service 
controls, clarifies recordkeeping requirements for device failure and 
complaint investigations, clarifies requirements for verifying/
validating production processes and process or product changes, and 
clarifies requirements for product acceptance activities quality data 
evaluations and corrections of nonconforming product/quality problems.
    Requirements are compatible with specifications in the 
international standards ``ISO 9001: Quality Systems Model for Quality 
Assurance in Design/Development, Production, Installation, and 
Servicing.'' The CGMP/QS information collections will assist FDA 
inspections of manufacturers for compliance with QS requirements 
encompassing design, production, installation, and servicing processes.
    Section 820.20(a) through (e) requires management with executive 
responsibility to establish, maintain, and/or review the following 
topics: (1) The quality policy, (2) the organizational structure, (3) 
the quality plan, and (4) the quality system procedures of the 
organization.
    Section 820.22 requires the conduct and documentation of QS audits 
and reaudits.
    Section 820.25(b) requires the establishment of procedures to 
identify training needs and documentation of such training.
    Section 820.30(a)(1) and (b) through (j), requires in respective 
order, the establishment, maintenance, and/or documentation of the 
following topics: (1) Procedures to control design of class III and 
class II devices and certain class I devices as listed therein; (2) 
plans for design and development activities and updates; (3) procedures 
identifying, documenting, and approving design input requirements; (4) 
procedures defining design output, including acceptance criteria, and 
documentation of approved records; (5) procedures for formal review of 
design results and documentation of results in the design history file 
(DHF); (6) procedures for verifying device design and documentation of 
results and approvals in the DHF; (7) procedures for validating device 
design, including documentation of results in the DHF; (8) procedures 
for translating device design into production specifications; (9) 
procedures for documenting, verifying, and validating approved design 
changes before implementation of changes; and (10) the records and 
references constituting the DHF for each type of device.
    Section 820.40 requires manufacturers to establish and maintain 
procedures controlling approval and distribution of required documents 
and document changes.
    Section 820.40(a) and (b) requires the establishment and 
maintenance of procedures for the review, approval, issuance, and 
documentation of required records (documents) and changes to those 
records.
    Section 820.50(a)(1), (a)(2), (a)(3), and (b) requires the 
establishment and maintenance of procedures and requirements to ensure 
service and product quality, records of acceptable suppliers, and 
purchasing data

[[Page 36094]]

describing specified requirements for products and services.
    Sections 820.60 and 820.65 require, respectively, the establishment 
and maintenance of procedures for identifying all products from receipt 
to distribution and for using control numbers to track surgical 
implants and life-sustaining or supporting devices and their 
components.
    Section 820.70(a)(1) through (a)(5), (b) through (e), (g)(1) 
through (g)(3), (h), and (i) requires the establishment, maintenance, 
and/or documentation of the following topics: (1) Process control 
procedures; (2) procedures for verifying or validating changes to 
specification, method, process, or procedure; (3) procedures to control 
environmental conditions and inspection result records; (4) 
requirements for personnel hygiene; (5) procedures for preventing 
contamination of equipment and products; (6) equipment adjustment, 
cleaning, and maintenance schedules; (7) equipment inspection records; 
(8) equipment tolerance postings, procedures for utilizing 
manufacturing materials expected to have an adverse effect on product 
quality; and (9) validation protocols and validation records for 
computer software and software changes.
    Sections 820.72(a), (b)(1), and (b)(2) and 820.75(a) through (c) 
require, respectively, the establishment, maintenance, and/or 
documentation of the following topics: (1) Equipment calibration and 
inspection procedures; (2) national, international or in-house 
calibration standards; (3) records that identify calibrated equipment 
and next calibration dates; (4) validation procedures and validation 
results for processes not verifiable by inspections and tests; (5) 
procedures for keeping validated processes within specified limits; (6) 
records for monitoring and controlling validated processes; and (7) 
records of the results of revalidation where necessitated by process 
changes or deviations.
    Sections 820.80(a) through (e) and 820.86, respectively, require 
the establishment, maintenance, and/or documentation of the following 
topics: (1) Procedures for incoming acceptance by inspection, test, or 
other verification; (2) procedures for ensuring that in-process 
products meet specified requirements and the control of product until 
inspection and tests are completed; (3) procedures for, and records 
that show, incoming acceptance or rejection is conducted by 
inspections, tests or other verifications; (4) procedures for, and 
records that show, finished devices meet acceptance criteria and are 
not distributed until device master record (DMR) activities are 
completed; (5) records in the device history record (DHR) showing 
acceptance dates, results, and equipment used; and (6) the acceptance/
rejection identification of products from receipt to installation and 
servicing.
    Sections 820.90(a), (b)(1), and (b)(2) and 820.100 require, 
respectively, the establishment, maintenance and/or documentation of 
the following topics: (1) Procedures for identifying, recording, 
evaluating, and disposing of nonconforming product; (2) procedures for 
reviewing and recording concessions made for, and disposition of, 
nonconforming product; (3) procedures for reworking products, 
evaluating possible adverse rework effect and recording results in the 
DHR; (4) procedures and requirements for corrective and preventive 
actions, including analysis, investigation, identification and review 
of data, records, causes, and results; and (5) records for all 
corrective and preventive action activities.
    Section 820.100(a)(1) through (a)(7) states that procedures and 
requirements shall be established and maintained for corrective/
preventive actions, including the following: (1) Analysis of data from 
process, work, quality, servicing records; investigation of 
nonconformance causes; (2) identification of corrections and their 
effectiveness; (3) recording of changes made; and (4) appropriate 
distribution and managerial review of corrective and preventive action 
information.
    Section 820.120 states that manufacturers shall establish/maintain 
procedures to control labeling storage/application; and examination/
release for storage and use, and document those procedures.
    Sections 820.120(b) and (d), 820.130, 820.140, 820.150(a) and (b), 
820.160(a) and (b), and 820.170(a) and (b), respectively, require the 
establishment, maintenance, and/or documentation of following topics: 
(1) Procedures for controlling and recording the storage, examination, 
release, and use of labeling; (2) the filing of labels/labeling used in 
the DHR; (3) procedures for controlling product storage areas and 
receipt/dispatch authorizations; (4) procedures controlling the release 
of products for distribution; (5) distribution records that identify 
consignee, product, date, and control numbers; and (6) instructions, 
inspection and test procedures that are made available, and the 
recording of results for devices requiring installation.
    Sections 820.180(b) and (c), 820.181(a) through (e), 820.184(a) 
through (f), and 820.186 require, respectively, the maintenance of 
records that are: (1) Retained at prescribed site(s), made readily 
available and accessible to FDA and retained for the device's life 
expectancy or for 2 years; (2) contained or referenced in a DMR 
consisting of device, process, quality assurance, packaging and 
labeling, and installation, maintenance, and servicing specifications 
and procedures; (3) contained in a DHR and demonstrate the manufacture 
of each unit, lot, or batch of product in conformance with DMR and 
regulatory requirements, include manufacturing and distribution dates, 
quantities, acceptance documents, labels and labeling, control numbers; 
and (4) contained in a quality system record (QSR), consisting of 
references, documents, procedures, and activities not specific to 
particular devices.
    Sections 820.198(a) through (c) and 820.200(a) through (d), 
respectively, require the establishment, maintenance, and/or 
documentation of the following topics: (1) Complaint files and 
procedures for receiving, reviewing and evaluating complaints; (2) 
complaint investigation records identifying the device, complainant, 
and relationship of the device to the incident; (3) complaint records 
that are reasonably accessible to the manufacturing site or at 
prescribed sites; (4) procedures for performing and verifying that 
device servicing requirements are met and that service reports 
involving complaints are processed as complaints; and (5) service 
reports that record the device, service activity, and test and 
inspection data.
    Section 820.250 requires the establishment and maintenance of 
procedures to identify valid statistical techniques necessary to verify 
process and product acceptability; and sampling plans, when used, which 
are written and based on valid statistical rationale; and procedures 
for ensuring adequate sampling methods. The CGMP/QS regulation amends 
and revises the CGMP requirements for medical devices set out under 
part 820. The regulation adds design and purchasing controls; modifies 
previous critical device requirements; revises previous validation and 
other requirements; and harmonizes device CGMP requirements with QS 
specifications in the international standard ``ISO 9001: Quality 
Systems Model for Quality Assurance in Design/Development, Production, 
Installation, and Servicing.'' The rule does not apply to manufacturers 
of components or parts of finished devices, nor to manufacturers of 
human blood and blood components subject to 21 CFR part 606. With 
respect to devices classified in class I, design control requirements 
apply only to class

[[Page 36095]]

I devices listed in Sec.  820.30(a)(2) of the regulation. The rule 
imposes burden upon: (1) Finished device manufacturer firms, which are 
subject to all recordkeeping requirements; (2) finished device contract 
manufacturers, specification developers; and (3) repacker, relabelers, 
and contract sterilizer firms, which are subject only to requirements 
applicable to their activities. In addition, remanufacturers of 
hospital single-use devices (SUDs) will now be considered to have the 
same requirements as manufacturers in regard to this regulation. The 
establishment, maintenance and/or documentation of procedures, records, 
and data required by this regulation will assist FDA in determining 
whether firms are in compliance with CGMP requirements, which are 
intended to ensure that devices meet their design, production, 
labeling, installation, and servicing specifications and, thus are 
safe, effective and suitable for their intended purpose. In particular, 
compliance with CGMP design control requirements should decrease the 
number of design-related device failures that have resulted in deaths 
and serious injuries.
    The CGMP/QS regulation applies to approximately 8,924 respondents. 
These recordkeepers consist of 8,945 original respondents and an 
estimated 18 hospitals that remanufacture or reuse SUDs. They include 
manufacturers, subject to all requirements and contract manufacturers, 
specification developers, repackers, relabelers, and contract 
sterilizers, subject only to requirements applicable to their 
activities. Hospital remanufacturers of SUDs are now defined to be 
manufacturers under guidelines issued by FDA's Center for Devices and 
Radiological Health (CDRH), Office of Surveillance and Biometrics. 
Respondents to this collection have no reporting activities, but must 
make required records available for review or copying during FDA 
inspection. The regulation contains additional recordkeeping 
requirements in such areas as design control, purchasing, installation, 
and information relating to the remanufacture of SUDs. The estimates 
for this burden are derived from those incremental tasks that were 
determined when the new CGMP/QS regulation became final as well as 
those carryover requirements. The carryover requirements are based on 
decisions made by the agency on July 16, 1992, under OMB Control Number 
0910-0073, which still provides valid base line data.
    FDA estimates the burden for this collection of information as 
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                                                                                       Total Operating
             21 CFR Section                    No. of       Annual Frequency per    Total Annual        Hours Per     and  Maintenance     Total Hours
                                            Recordkeepers       Recordkeeping          Records           Record             Costs
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820.20(a)                                            8,924                     1             8,924                 7  ................            62,468
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820.20(b)                                            8,924                     1             8,924                 4  ................            35,696
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820.20(c)                                            8,924                     1             8,924                 6  ................            53,544
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820.20(d)                                            8,924                     1             8,924                10  ................            89,240
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820.20(e)                                            8,924                     1             8,924                10  ................            89,240
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820.22                                               8,924                     1             8,924                33  ................           294,492
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820.25(b)                                            8,924                     1             8,924                13  ................           116,012
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820.30(a)(1)                                         8,924                     1             8,924                 2  ................            17,848
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820.30(b)                                            8,924                     1             8,924                 6  ................            53,544
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820.30(c)                                            8,924                     1             8,924                 2  ................            17,848
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820.30(d)                                            8,924                     1             8,924                 2  ................            17,848
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820.30(e)                                            8,924                     1             8,924                23  ................           205,252
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820.30(f)                                            8,924                     1             8,924                37  ................           330,188
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820.30(g)                                            8,924                     1             8,924                37  ................           330,188
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820.30(h)                                            8,924                     1             8,924                 3  ................            26,772
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820.30(i)                                            8,924                     1             8,924                17  ................           151,708
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820.30(j)                                            8,924                     1             8,924                 3  ................            26,772
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820.40                                               8,924                     1             8,924                 9  ................            80,316
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820.40(a) and (b)                                    8,924                     1             8,924                 2  ................            17,848
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820.50(a)(1) through (a)(3)                          8,924                     1             8,924                22         1,300,805           196,328
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820.50(b)                                            8,924                     1             8,924                 6  ................            53,544
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820.6                                                8,924                     1             8,924                 1  ................             8,924
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820.65                                               8,924                     1             8,924                 1  ................             8,924
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820.70(a)(1) through (a)(5)                          8,924                     1             8,924                 2  ................            17,848
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820.70(b) and (c)                                    8,924                     1             8,924                 2  ................            17,848
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820.70(d)                                            8,924                     1             8,924                 3  ................            26,772
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820.70(e)                                            8,924                     1             8,924                 2  ................            17,848
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820.70(g)(1) through (g)(3)                          8,924                     1             8,924                 1  ................             8,924
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820.70(h)                                            8,924                     1             8,924                 2  ................            17,848
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820.70(i)                                            8,924                     1             8,924                 8  ................            71,392
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820.72(a)                                            8,924                     1             8,924                 5  ................            44,620
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820.72(b)(1) and (b)(2)                              8,924                     1             8,924                 1  ................             8,924
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820.75(a)                                            8,924                     1             8,924                 3  ................            26,772
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820.75(b)                                            8,924                     1             8,924                 1  ................             8,924
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820.75(c)                                            8,924                     1             8,924                 1  ................             8,924
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820.80(a) through (e)                                8,924                     1             8,924                 5  ................            44,620
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820.86                                               8,924                     1             8,924                 1  ................             8,924
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820.90(a)                                            8,924                     1             8,924                 5  ................            44,620
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820.90(b)(1) and (b)(2)                              8,924                     1             8,924                 5  ................            44,620
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820.100(a)(1) through (a)(7)                         8,924                     1             8,924                12  ................           107,088
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820.100(b)                                           8,924                     1             8,924                 1  ................             8,924
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820.120(b)                                           8,924                     1             8,924                 1  ................             8,924
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820.120(d)                                           8,924                     1             8,924                 1  ................             8,924
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820.130                                              8,924                     1             8,924                 1  ................             8,924
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820.140                                              8,924                     1             8,924                 6  ................            53,544
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820.150(a) and (b)                                   8,924                     1             8,924                 6  ................            53,544
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820.160(a) and (b)                                   8,924                     1             8,924                 1  ................             8,924
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820.170(a) and (b)                                   8,924                     1             8,924                 2  ................            17,848
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820.180(b) and (c)                                   8,924                     1             8,924                 2  ................            17,848
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820.181(a) through (e)                               8,924                     1             8,924                 1  ................             8,924
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820.184(a) through (f)                               8,924                     1             8,924                 1  ................             8,924
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820.186                                              8,924                     1             8,924                 1  ................             8,924
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[[Page 36097]]


820.198(a) through (c)                               8,924                     1             8,924                 5  ................            44,620
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820.200(a) and (d)                                   8,924                     1             8,924                 3  ................            26,772
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820.25                                               8,924                     1             8,924                 1  ................             8,924
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Total                                     ................  ....................  ................  ................         1,300,805         3,105,552
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\1\ There are no capital costs associated with this collection of information.

Explanation of Recordkeeping Burden Estimate

    FDA estimates respondents will have a total annual recordkeeping 
burden of approximately 3,105,552 hours. This figure also consists of 
approximately 143,052 hours spent on a startup basis by 734 new firms.
    Burden (labor) hour and cost estimates were originally developed 
under FDA contract by Eastern Research Group, Inc. (ERG) in 1996 when 
the CGMP/QS regulation became final. Additional factors considered in 
deriving estimates included the following:
     Establishment type: Query has been made of CDRH's 
registration/listing data bank and the current count was 7,748 domestic 
firms subject to CGMPs. It was also calculated that each year, the 
number of new domestic firms subject to CGMPs is 734. The average 
amount of firms therefore subject to CGMPs over the 3 years is 
therefore 8,924 and this figure has been used to calculate the total 
burden. Because the total number of registered firms is not static, the 
number of respondents will fluctuate from year to year resulting in 
slight changes to the overall burden.
     During the last report it was estimated that this number 
was 8,963. When the last set of numbers was calculated, FDA was still 
using a paper based system to register and list firms. On October 1, 
2007, FDA switched to an electronic system for registration and 
listing. Also at that time the Food and Drug Administration Amendments 
Act of 2007 instituted an establishment registration fee for some types 
of facilities. FDA believes that during the FY 2008 annual registration 
cycle, establishments that had previously registered but were not 
required to do so, removed themselves from inventory of active 
establishments. FDA believes that the current figures reported by the 
electronic system more accurately reflect the inventory of registered 
establishments.
     Potentially affected establishments: Except for 
manufacturers, not every type of firm is subject to every CGMP/QS 
requirement. For example, all are subject to Quality Policy (Sec.  
820.20(a)), Document Control (Sec.  820.40), and other requirements, 
whereas only manufacturers and specification developers are subject to 
Subpart C, Design Controls. The type of firm subject to each 
requirement was identified by the ERG.
     FDA estimated the burden hours (and costs) for the 
previous CGMP regulation in 1992. That estimate was submitted to OMB on 
May 4, 1992, under OMB Paperwork Reduction Act Control Number 0910-
0073. It was approved by OMB on July 16, 1992, and expired on June 30, 
1995. The methodology used is different than that used by ERG in 
estimating incremental tasks when the new CGMP/QS became final rule. 
Nevertheless, the agency believes its 1992 estimate adequately 
represents labor hours (and costs) needed to comply with previous CGMP 
requirements carried over into the new CGMP/QS regulation. The 1992 
estimate used 9,289 respondents (rather than 8,924 respondents), which 
compensates for differences in methodology.

    Dated: June 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15338 Filed 6-23-10; 8:45 am]
BILLING CODE 4160-01-S

