[Federal Register Volume 63, Number 114 (Monday, June 15, 1998)]
[Notices]
[Pages 32667-32672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15812]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0357]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by July
15, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Medical Devices; Current Good Manufacturing Practice (CGMP) Quality
System (QS) (21 CFR Part 820)--(OMB Control Number 0910-0073--
Reinstatement)
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 the authority provided by this
statutory provision is found in part 820 of the Code of Federal
Regulations (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. 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 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
[[Page 32668]]
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 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
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.
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 final CGMP/QS regulation amended and revised the CGMP
requirements for medical devices set out at part 820. The final rule
added design and purchasing controls; modified previous critical device
requirements; revised previous validation and other requirements; and
harmonized 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 imposed 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. 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
[[Page 32669]]
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.
FDA estimates information collection burdens imposed by the
addition, modification and revision of CGMP requirements in the final
rule as follows:
[[Page 32670]]
Table 1.--Annual Recordkeeping Burden
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Total Hours\1\
Number of Annual Total Annual Hours per (incremental Total Hours\2\ Total Operating &
21 CFR Section Recordkeepers Frequency of Records Recordkeeper increase in (prior continuing Maintenance Costs
Recordkeeping burdens) burdens)
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820.20(a) 7,237 1 7,237 10.96 79,386 ------- -------
820.20(b) 7,237 1 7,237 6.38 35,285 10,885 --------
820.20(c) 7,237 1 7,237 10.28 74,364 ------- -------
820.20(d) 7,237 1 7,237 16.49 119,305 ------- -------
820.20(e) 7,237 1 7,237 16.49 119,305 ------- -------
820.22(a) 7,237 1 7,237 53.53 376,507 10,885 -------
820.25(b) 7,237 1 7,237 21.13 152,896 ------- -------
820.30(a)(1) 7,237 1 7,237 2.92 21,162 ------- -------
820.30(b) 7,237 1 7,237 9.91 71,718 ------- -------
820.30(c) 7,237 1 7,237 2.92 21,162 ------- -------
820.30(d) 7,237 1 7,237 2.92 21,162 ------- -------
820.30(e) 7,237 1 7,237 38.98 282,115 ------- -------
820.30(f) 7,237 1 7,237 62.37 451,342 ------- $27,363,204
820.30(g) 7,237 1 7,237 62.37 451,342 ------- -------
820.30(h) 7,237 1 7,237 5.56 40,236 ------- -------
820.30(I) 7,237 1 7,237 28.77 208,173 ------- -------
820.30(j) 7,237 1 7,237 4.40 31,848 ------- -------
820.40 7,237 1 7,237 13.61 85,081 13,420 -------
820.40(a) and (b) 7,237 1 7,237 2.04 ------- 14,748 -------
820.50(a)(1) through (a)(3) 7,237 1 7,237 34.34 225,240 23,251 $898,500
820.50(b) 7,237 1 7,237 10.04 72,679 ------- -------
820.60 7,237 1 7,237 0.54 3,914 ------- -------
820.65 7,237 1 7,237 0.67 ------- 4,839 -------
820.70(a)(1) through (a)(5) 7,237 1 7,237 1.85 ------- 13,420 -------
820.70(b) and (c) 7,237 1 7,237 1.85 ------- 13,420 -------
820.70(d) 7,237 1 7,237 4.11 22,335 7,374 -------
820.70(e) 7,237 1 7,237 1.85 ------- 13,420 -------
820.70(g)(1) through (g)(3) 7,237 1 7,237 1.43 ------- 10,347 -------
820.70(h) 7,237 1 7,237 1.85 ------- 13,420 -------
820.70(i) 7,237 1 7,237 11.26 68,092 13,420 -------
820.72(a) 7,237 1 7,237 7.26 42,165 10,347 -------
820.72(b)(1) through (b)(3) 7,237 1 7,237 1.43 ------- 10,347 -------
820.75(a) 7,237 1 7,237 3.81 20,172 7,374 -------
820.75(b) 7,237 1 7,237 1.02 ------- 7,374 -------
820.75(b)(2) 7,237 1 7,237 1.17 1,096 7,374 -------
820.75(c) 7,237 1 7,237 1.17 1,096 7,374 -------
820.80(a) through (e) 7,237 1 7,237 4.80 ------- 34,721 -------
820.86 7,237 1 7,237 0.79 ------- 5,735 --------
820.90(a) 7,237 1 7,237 7.39 44,217 9,272 -------
820.90(b)(1) and (b)(2) 7,237 1 7,237 7.39 44,217 9,272 -------
820.100(a)(1) through (a)(7) 7,237 1 7,237 20.50 145,144 3,226 -------
820.100(b) 7,237 1 7,237 1.28 ------- 9,272 -------
820.120 7,237 1 7,237 0.45 ------- 3,226 -------
820.120(b) 7,237 1 7,237 0.45 ------- 3,226 -------
820.120(d) 7,237 1 7,237 0.45 ------- 3,226 -------
820.130 7,237 1 7,237 0.45 ------- 3,226 -------
820.140 7,237 1 7,237 10.12 68,418 4,839 -------
820.150(a) and (b) 7,237 1 7,237 9.45 68,418 ------- -------
820.160(a) and (b) 7,237 1 7,237 0.67 ------- 4,839 -------
820.170(a) and (b) 7,237 1 7,237 1.50 ------- 10,885 -------
820.180(b) and (c) 7,237 1 7,237 1.50 ------- 10,885 -------
820.181(a) through (e) 7,237 1 7,237 1.21 ------- 8,783 -------
820.184(a) through (f) 7,237 1 7,237 1.41 ------- 10,240 -------
[[Page 32671]]
820.186 7,237 1 7,237 0.40 ------- 2,873 -------
820.198(a) through (c) 7,237 1 7,237 6.42 26,850 19,644 -------
820.200(a) through (d) 7,237 1 7,237 4.35 31,459 ------- -------
820.250 7,237 1 7,237 0.67 ------- 4,839 -------
Totals 7,237 1 7,237 3,527,901 375,268 $28,261,704
Grand Totals\3\ 3,903,169 $28,261,704
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\1\ Incremental increase in burden hours to achieve compliance with additional requirements in revised regulation.
\2\ Recordkeeping hours for prior requirements carried over into revised regulation, as approved by OMB on July 16, 1992, and expired on June 30, 1995
(OMB No. 0910-0073).
\3\ Note: Totals may not add due to rounding.
[[Page 32672]]
Under OMB information collection 0910-0073, Current Good Manufacturing
Practices (CGMP) for Medical Devices, there were 375,266 hours approved
for recordkeeping information collections contained in part 820. These
hours included 114,882 burden hours as a one time start up expenditure
for 650 new firms. The additional requirements contained in Current
Good Manufacturing Practice; Quality system (CGMP/QS) regulation will
add 3,527,901 burden hours to the burden, resulting in a total
recordkeeping burden of 3,903,169 hours. The 3,527,901 burden hours
includes 1,433,579 burden hours for a one time start up expenditure for
7,237 manufacturers and 2,094,321 burden hours expended annually by
7,237 manufacturers.
The recordkeeping estimate includes approximately 9.6 times as many
manufacturers with a one time start up expenditure, due to the addition
of the design control requirements. Further, the recordkeeping burden
hour calculations were estimated using a complex methodology involving
the estimated noncompliance ratio for small, medium, large, and very
large manufacturers multiplied by the number of manufacturers in each
category. These calculations factor in a rate of product innovation for
new products, including 510(k) devices.
Approximately 85 percent of the additional burden hours for CGMP/QS
regulation originate from the following four subparts of part 820: (1)
Subpart B--Quality System Requirements; (2) Subpart C--Design controls;
(3) Subpart E--Purchasing Controls; and (4) Subpart J--Corrective and
Preventive Action. Over 45 percent of the 3,527,901 burden hours are
attributed directly to the addition of design control requirements. The
purchasing control requirements and the respective recordkeeping burden
are approximately 8 percent of the additional recordkeeping burden.
Dated: June 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15812 Filed 6-12-98; 8:45 am]
BILLING CODE 4160-01-F