[Federal Register: February 28, 2001 (Volume 66, Number 40)]
[Notices]
[Page 12798-12802]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe01-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0063]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Current Good Manufacturing Practice
Quality System Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements related to the medical devices current good manufacturing
practice (CGMP) quality system (QS) regulation.
DATES: Submit written comments or electronic comments on the collection
of information by April 30, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
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: (1) Whether the proposed collection of information
is necessary
[[Page 12799]]
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 (CGMP) Quality
System (QS) Regulation--21 CFR Part 820 (OMB Control No. 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, preproduction 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 the authority provided by this
statutory provision is found in part 820 (21 CFR part 820) of the Code
of Federal Regulations 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.
Section 820.20(a) through (e) requires management with executive
responsibility to establish, maintain, and/or review: The quality
policy; the organizational structure; the quality plan; and 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 the following
respective order, the establishment, maintenance, and/or documentation
of: Procedures to control design of class III and class II devices, and
certain class I devices as listed therein; plans for design and
development activities and updates; procedures identifying,
documenting, and approving design input requirements; procedures
defining design output, including acceptance criteria, and
documentation of approved records; procedures for formal review of
design results and documentation of results in the design history file
(DHF); procedures for verifying device design and documentation of
results and approvals in the DHF; procedures for validating device
design, including documentation of results in the DHF; procedures for
translating device design into production specifications; procedures
for documenting, verifying and validating approved design changes
before implementation of changes; and the records and references
constituting the DHF for each type of device.
Section 820.40 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 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) through (e), and (g) through (i) requires the
establishment, maintenance, and/or documentation of: Process control
procedures; procedures for verifying or validating changes to
specification, method, process, or procedure; procedures to control
environmental conditions and inspection result records; requirements
for personnel hygiene; procedures for preventing contamination of
equipment and products; equipment adjustment, cleaning and maintenance
schedules; equipment inspection records; equipment tolerance postings;
procedures for utilizing manufacturing materials expected to have an
adverse effect on product quality; and validation protocols and
validation records for computer software and software changes.
Sections 820.72 and 820.75(a), (b), (b)(2), and (c) require,
respectively, the establishment, maintenance, and/or documentation of:
Equipment calibration and inspection procedures; national,
international or in-house calibration standards; records that identify
calibrated equipment and next calibration dates; validation procedures
and validation results for processes not verifiable by inspections and
tests; procedures for keeping validated processes within specified
limits; records for monitoring and controlling validated processes; and
records of the results of revalidation where necessitated by process
changes or deviations.
Sections 820.80 and 820.86, respectively, require the
establishment, maintenance, and/or documentation of: Procedures for
incoming acceptance by inspection, test or other verification;
procedures for ensuring that in-process products meet specified
requirements and the control of product until inspection and tests are
completed; procedures for, and records that show, incoming acceptance
or rejection is conducted by inspections, tests or other verifications;
procedures for, and records that show, finished devices meet acceptance
criteria and are not distributed until device master (DMR) activities
are completed; records in the device history record (DHR) showing
acceptance dates, results and equipment used; and the acceptance/
rejection identification of products from receipt to installation and
servicing.
Sections 820.90 and 820.100 require, respectively, the
establishment, maintenance and/or documentation of: Procedures for
identifying, recording, evaluating, and disposing of nonconforming
product; procedures for reviewing and recording concessions made for,
and disposition of, nonconforming product; procedures for reworking
products, evaluating possible adverse rework effect and recording
results in the DHR; procedures and requirements for corrective and
preventive actions, including analysis, investigation, identification
and review of data, records, causes and results; and records for all
corrective and preventive action activities.
Sections 820.120(b) and (d), 820.130, 820.140, 820.150, 820.160,
and 820.170, respectively, require the establishment, maintenance, and/
or documentation of: Procedures for controlling and recording the
storage, examination, release and use of labeling; the filing of
labels/labeling used in the DHR; procedures for controlling product
storage areas and receipt/dispatch authorizations; procedures for
controlling the release of products for distribution; distribution
records that identify consignee, product, date and control numbers; and
instructions, inspection and test procedures that are made available,
and the recording of results for devices requiring installation.
[[Page 12800]]
Sections 820.180(b) and (c), 820.181, 820.184, and 820.186 require,
respectively, the maintenance of records: 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; 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; that are contained in DHR's,
demonstrate the manufacture of each unit, lot or batch of product in
conformance with DMR and regulatory requirements, and include
manufacturing and distribution dates and quantities, acceptance
documents, labels and labeling, and control numbers; and 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) and (d),
respectively, require the establishment, maintenance and/or
documentation of: Complaint files and procedures for receiving,
reviewing, and evaluating complaints; complaint investigation records
identifying the device, complainant, and relationship of the device to
the incident; complaint records that are reasonably accessible to the
manufacturing site or at prescribed sites; procedures for performing
and verifying that device servicing requirements are met and that
service reports involving complaints are processed as complaints; and
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, that
are written and based on a 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 at part 820. It adds design and purchasing
controls; modifies previous critical device requirements; revises
previous validation and other requirements; and harmonizes device CGMP
requirements with quality system specifications in the international
standard, ISO (International Organization for Standardization)
9001:1994 ``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 burdens upon finished device manufacturer firms,
which are subject to all recordkeeping requirements, and upon finished
device contract manufacturer, specification developer, repacker and
relabeler, and contract sterilizer firms, which are subject only to
requirements applicable to their activities. Due to modifications to
the guidance given for remanufacturers of hospital single use devices,
reusers of hospital single-use devices 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 final 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.
If FDA did not impose these recordkeeping requirements, it
anticipates that design-related device failures would continue to occur
in the same numbers as before and continue to result in a significant
number of device recalls and preventable deaths and serious injuries.
Moreover, manufacturers would be unable to take advantage of
substantial savings attributable to reduced recall costs, improved
manufacturing efficiency, and improved access to international markets
through compliance with CGMP requirements that are harmonized with
international quality system standards.
The CGMP/QS regulation applies to some 9,229 respondents. These
recordkeepers consist of 7,229 original respondents and an estimated
2,000 hospitals that remanufacture or reuse single use medical devices.
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 single use medical devices
(SUD's) are now defined to be manufacturers under guidelines issued by
the Center for Devices and Radiological Health's (CDRH's) 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 single use medical devices. The estimates for burden are derived
from those incremental tasks that were determined when the new CGMP/QS
regulation became final (October 7, 1996, 61 FR 52602) 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 Paperwork
Reduction Act submission No. 0910-0073. This still provides valid
baseline data.
FDA estimates respondents will have a total annual recordkeeping
burden of approximately 3,167,670 hours (shown as 3,167,670 in table 1,
of this document, of this justification statement due to rounding).
This figure also consists of approximately 114,882 hours spent on a
startup basis by 650 new firms. Table 1 below identifies burden
estimates per sections of the regulation.
FDA estimates information collection burdens imposed as follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Total Operating &
Recordkeepers Recordkeeping Records Recordkeeper Maintenance Costs
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820.20(a) 9,229 1 9,229 6.58 60,727
820.20(b) 9,229 1 9,229 4.43 40,884
820.20(c) 9,229 1 9,229 6.17 56,943
820.20(d) 9,229 1 9,229 9.89 91,275
[[Page 12801]]
820.20(e) 9,229 1 9,229 9.89 91,275
820.22 9,229 1 9,229 32.72 301,973
820.25(b) 9,229 1 9,229 12.68 117,024
820.30(a)(1) 9,229 1 9,229 1.75 16,151
820.30(b) 9,229 1 9,229 5.95 54,913
820.30(c) 9,229 1 9,229 1.75 16,151
820.30(d) 9,229 1 9,229 1.75 16,151
820.30(e) 9,229 1 9,229 23.39 215,866
820.30(f) 9,229 1 9,229 37.42 345,349
820.30(g) 9,229 1 9,229 37.42 345,349
820.30(h) 9,229 1 9,229 3.34 30,825
820.30(i) 9,229 1 9,229 17.26 159,293
820.30(j) 9,229 1 9,229 2.64 24,365
820.4 9,229 1 9,229 8.91 82,230
820.40(a) and (b) 9,229 1 9,229 2.04 18,827
820.50(a)(1) to (a)(3) 9,229 1 9,229 21.9 202,115 $1,181,925
820.50(b) 9,229 1 9,229 6.02 55,559
821 9,229 1 9,229 0.32 2,953
821 9,229 1 9,229 0.67 6,183
820.70(a)(1) to (a)(5) 9,229 1 9,229 1.85 17,074
820.70(b) and (c) 9,229 1 9,229 1.85 17,074
820.70(d) 9,229 1 9,229 2.87 26,487
820.70(e) 9,229 1 9,229 1.85 17,074
820.70(g)(1) to (g)(3) 9,229 1 9,229 1.43 13,197
820.70(h) 9,229 1 9,229 1.85 17,074
820.70(i) 9,229 1 9,229 7.5 69,218
820.72(a) 9,229 1 9,229 4.92 45,407
820.72(b)(1) to (b)(2) 9,229 1 9,229 1.43 13,197
820.75(a) 9,229 1 9,229 2.69 24,826
820.75(b) 9,229 1 ,9229 1.02 9,414
820.75(c) 9,229 1 9,229 1.11 10,244
820.80(a) to (e) 9,229 1 9,229 4.8 44,299
820.86 9,229 1 9,229 0.79 7,291
820.90(a) 9,229 1 9,229 4.95 45,684
820.90(b)(1) and (b)(2) 9,229 1 9,229 4.95 45,684
820.100 (a)(1) to (a)(7) 9,229 1 9,229 12.48 115,178
820.100(b) 9,229 1 9,229 1.28 11,813
820 9,229 1 9,229 0.45 4,153
820.120(b) 9,229 1 9,229 0.45 4,153
820.120(d) 9,229 1 9,229 0.45 4,153
820.130 9,229 1 9,229 0.45 4,153
820.140 9,229 1 9,229 6.34 58,512
820.150(a) and (b) 9,229 1 9,229 5.67 52,328
820.160(a) and (b) 9,229 1 9,229 0.67 6,183
820.170(a) and (b) 9,229 1 9,229 1.5 13,844
820.180(b) and (c) 9,229 1 9,229 1.5 13,844
820.181(a) to (e) 9,229 1 9,229 1.21 11,167
820.184(a) to (f) 9,229 1 9,229 1.41 13,013
820.186 9,229 1 9,229 0.4 3,692
820.198(a) to (c) 9,229 1 9,229 4.94 45,591
820.200(a) and (d) 9,229 1 9,229 2.61 24,088
820.250 9,229 1 9,229 0.67 6,183
Totals 3,167,673 $1,181,925
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\1\ There are no capital costs associated with this collection of information.
Burden (labor) hour and cost estimates were developed under FDA
contract by the 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:
Establishment type: Query has been made of CDRH's
registration/listing data bank and has counted 7,229 domestic firms
subject to CGMP's. They were then grouped as: Manufacturers (5,463),
contract manufacturers (204), specification developers (960),
repackers/relabelers (574), remanufacturer (21) and contract
sterilizers (7). In addition, hospitals that
[[Page 12802]]
reuse or remanufacture devices are now considered manufacturers under
new FDA guidance. It is estimated that out of the 6,000 hospitals in
the United States, one-third of them (or 2,000 hospitals) will reuse or
remanufacture single use medical devices. Thus, the number of
manufacturers will increase from 5,463 to 7,463 making the total number
of firms subject to CGMP's 9,229.
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 part 820 Subpart C--Design Controls. The type of firm
subject to each requirement was identified by 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 submission No. 0910-0073. It was
approved by OMB on July 16, 1992, and it 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 a 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 9,229 respondents), which
compensates for differences in methodology.
FDA estimates that some 650 ``new'' establishments (marketing
devices for the first time) will expend some 114,882 ``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:
40 percent--to requirements dealing with manufacturing specifications,
process controls and the DHR; 20 percent--to requirements dealing with
components and acceptance activities; 25 percent--to requirements
dealing with equipment, records (the DMR and QSR), complaint
investigations, labeling/packaging and reprocessing/investigating
product nonconformance; and 15 percent--to quality audit, traceability,
handling, distribution, statistical, and other requirements.
Dated: February 22, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-4850 Filed 2-27-01; 8:45 am]
BILLING CODE 4160-01-F