[Federal Register: July 9, 2007 (Volume 72, Number 130)]
[Notices]
[Page 37235-37239]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy07-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0229]
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
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 information
collection, 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 written or electronic comments on the collection of
information by September 7, 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.
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 (the Secretary) 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 quality system
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 quality
system 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
[[Page 37236]]
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
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 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: (1) That are 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) that are contained or referenced in a
DMR consisting of device, process, quality assurance, packaging and
labeling, and installation, maintenance, and servicing specifications
and procedures; (3) that are 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) that are 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,
[[Page 37237]]
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 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 8,963 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 carry-over requirements. The carry-over requirements are based on
decisions made by the agency on July 16, 1992, under OMB clearance
submission 0910-0073, which still provides valid baseline data.
FDA estimates respondents will have a total annual recordkeeping
burden of approximately 3,076,370 hours. This figure also consists of
approximately 143,052 hours spent on a startup basis by 650 new firms.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Hours Hours per Record Total Hours
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820.20(a) 8,963 1 8,963 6.58 58,977
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820.20(b) 8,963 1 8,963 4.43 39,706
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820.20(c) 8,963 1 8,963 6.17 55,302
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820.20(d) 8,963 1 8,963 9.89 88,644
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820.20(e) 8,963 1 8,963 9.89 88,644
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820.22 8,963 1 8,963 32.72 293,269
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820.25(b) 8,963 1 8,963 12.68 113,651
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820.30(a)(1) 8,963 1 8,963 1.75 15,685
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820.30(b) 8,963 1 8,963 5.95 53,330
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820.30(c) 8,963 1 8,963 1.75 15,685
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820.30(d) 8,963 1 8,963 1.75 15,685
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820.30(e) 8,963 1 8,963 23.39 209,645
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[[Page 37238]]
820.30(f) 8,963 1 8,963 37.42 335,395
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820.30(g) 8,963 1 8,963 37.42 335,395
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820.30(h) 8,963 1 8,963 3.34 29,936
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820.30(i) 8,963 1 8,963 17.26 154,701
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820.30(j) 8,963 1 8,963 2.64 23,662
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820.40 8,963 1 8,963 8.91 79,860
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820.40(a) and (b) 8,963 1 8,963 2.04 18,285
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820.50(a)(1) 8,963 1 8,963 21.90 196,290
through (a)(3)
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820.50(b) 8,963 1 8,963 6.02 53,957
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820.6 8,963 1 8,963 0.32 2,868
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820.65 8,963 1 8,963 0.67 6,005
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820.70(a)(1) 8,963 1 8,963 1.85 16,582
through (a)(5)
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820.70(b) and (c) 8,963 1 8,963 1.85 16,582
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820.70(d) 8,963 1 8,963 2.87 25,724
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820.70(e) 8,963 1 8,963 1.85 16,582
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820.70(g)(1) 8,963 1 8,963 1.43 12,817
through (g)(3)
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820.70(h) 8,963 1 8,963 1.85 16,582
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820.70(i) 8,963 1 8,963 7.50 67,223
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820.72(a) 8,963 1 8,963 4.92 44,098
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820.72(b)(1) and 8,963 1 8,963 1.43 12,817
(b)(2)
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820.75(a) 8,963 1 8,963 2.69 24,110
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820.75(b) 8,963 1 8,963 1.02 9,142
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820.75(c) 8,963 1 8,963 1.11 9,949
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820.80(a) through 8,963 1 8,963 4.80 43,022
(e)
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820.86 8,963 1 8,963 0.79 7,081
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820.90(a) 8,963 1 8,963 4.95 44,367
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820.90(b)(1) and 8,963 1 8,963 4.95 44,367
(b)(2)
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820.100 (a)(1) 8,963 1 8,963 12.48 111,858
through (a)(7)
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820.100(b) 8,963 1 8,963 1.28 11,473
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820.120(b) 8,963 1 8,963 0.45 4,033
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820.120(d) 8,963 1 8,963 0.45 4,033
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820.130 8,963 1 8,963 0.45 4,033
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820.140 8,963 1 8,963 6.34 56,825
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820.150(a) and 8,963 1 8,963 5.67 50,820
(b)
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820.160(a) and 8,963 1 8,963 0.67 6,005
(b)
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820.170(a) and 8,963 1 8,963 1.50 13,445
(b)
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[[Page 37239]]
820.180(b) and 8,963 1 8,963 1.50 13,445
(c)
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820.181(a) 8,963 1 8,963 1.21 10,845
through (e)
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820.184(a) 8,963 1 8,963 1.41 12,638
through (f)
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820.186 8,963 1 8,963 0.40 3,585
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820.198(a) 8,963 1 8,963 4.94 44,277
through (c)
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820.200(a) and 8,963 1 8,963 2.61 23,393
(d)
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820.25 8,963 1 8,963 0.67 6,005
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Totals ................. ................. ................. ................. 3,072,337
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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. These figures are still accurate.
Additional factors considered in deriving estimates included the
following:
Establishment Type: Query has been made of CDRH's
registration/listing databank and has counted 8,963 domestic firms
subject to CGMPs. In addition, hospitals that reuse or remanufacture
devices are now considered manufacturers under new FDA guidance. After
investigations of many hospitals and the changes in enforcements of
FDA's requirements for hospitals, the number of reuse or remanufactures
of single-use medical devices have decreased from the estimated 66 to
an estimated 18 hospitals. 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. Currently,
there are 8,963 firms subject to the CGMPs; an increase from the last
renewal of 8,254.
Potentially Affected Establishments: Except for
manufacturers, not every type of firm is subject to every CGMP/QS
requirement. For example, all are subject to FDA's quality policy
regulations (Sec. 820.20(a)), document control regulations (Sec.
820.40), and other requirements, whereas only manufacturers and
specification developers are subject to FDA's design controls
regulations (Sec. 820.30). The type of firm subject to each
requirement was identified by ERG.
FDA estimates the burden hours (and costs) based on the last
approved renewal for this information collection.
FDA estimates that some 650 ``new'' establishments (marketing
devices for the first time) will expend some 143,052 ``development''
hours on a one-time startup basis to develop records and procedures for
the CGMP/QS regulation.
FDA estimates that annual labor hours are apportioned as follows:
(1) 40 percent goes to requirements dealing with manufacturing
specifications, process controls, and the DHR; (2) 20 percent goes to
requirements dealing with components and acceptance activities; (3) 25
percent goes to requirements dealing with equipment, records (the DMR
and QSR), complaint investigations, labeling/packaging and
reprocessing/investigating product nonconformance; and 15 percent goes
to quality audit, traceability, handling, distribution, statistical,
and other requirements.
Dated: June 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13152 Filed 7-6-07; 8:45 am]
BILLING CODE 4160-01-S