[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46347-46351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18351]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0853]
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 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 September 30, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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
[[Page 46348]]
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
Regulation--21 CFR Part 820 (OMB Control Number 0910-0073)--Extension
Under section 520(f) of the Federal Food, Drug, and Cosmetic Act
(the FD&C 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 FD&C 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 FD&C 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 re-audits. 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) 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) 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
[[Page 46349]]
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, 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 added design and purchasing controls,
modified previous critical device requirements, revised previous
validation and other requirements, and harmonized 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,
or 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) are now to be considered to have the same requirements
as manufacturers in regard to the regulation. The establishment,
maintenance and/or documentation of procedures, records, and data
required by the regulation assists 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 25,986 respondents.
A query of the Agency's registration and listing database shows that
approximately 15,113 domestic and 10,873 foreign establishments are
respondents to this information collection.\1\ These recordkeepers
consist of 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 guidance issued by FDA's Center for
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Devices and Radiological Health, 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. 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 PRA burden placed on the
25,986 establishments is an average burden.
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\1\ Based on fiscal year 2012 data.
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FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity/21 CFR Section Number of recordkeepers records per Total annual records per Total hours
recordkeeper recordkeeping
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Quality policy--820.20(a).................... 25,986 1 25,986 7 181,902
Organization--820.20(b)...................... 25,986 1 25,986 4 103,944
Management review--820.20(c)................. 25,986 1 25,986 6 155,916
Quality planning--820.20(d).................. 25,986 1 25,986 10 259,860
Quality system procedures--820.20(e)......... 25,986 1 25,986 10 259,860
Quality audit--820.22........................ 25,986 1 25,986 33 857,538
Training--820.25(b).......................... 25,986 1 25,986 13 337,818
Design procedures--820.30(a)(1).............. 25,986 1 25,986 2 51,972
Design and development planning--820.30(b)... 25,986 1 25,986 6 155,916
Design input--820.30(c)...................... 25,986 1 25,986 2 51,972
Design output--820.30(d)..................... 25,986 1 25,986 2 51,972
Design review--820.30(e)..................... 25,986 1 25,986 23 597,678
Design verification--820.30(f)............... 25,986 1 25,986 37 961,482
Design validation--820.30(g)................. 25,986 1 25,986 37 961,482
Design transfer--820.30(h)................... 25,986 1 25,986 3 77,958
Design changes--820.30(i).................... 25,986 1 25,986 17 441,762
Design history file--820.30(j)............... 25,986 1 25,986 3 77,958
Document controls--820.40.................... 25,986 1 25,986 9 233,874
Documentation approval and distribution and 25,986 1 25,986 2 51,972
document changes--820.40(a) and (b).........
Purchasing controls--820.50(a)............... 25,986 1 25,986 22 571,692
Purchasing data--820.50(b)................... 25,986 1 25,986 6 155,916
Identification--820.60....................... 25,986 1 25,986 1 25,986
Traceability--820.65......................... 25,986 1 25,986 1 25,986
Production and process controls--820.70(a)... 25,986 1 25,986 2 51,972
Production and process changes and 25,986 1 25,986 2 51,972
environmental control--820.70(b) and (c)....
Personnel--820.70(d)......................... 25,986 1 25,986 3 77,958
Contamination control--820.70(e)............. 25,986 1 25,986 2 51,972
Equipment maintenance schedule, inspection, 25,986 1 25,986 1 25,986
and adjustment--820.70(g)(1) to (g)(3)......
Manufacturing material--820.70(h)............ 25,986 1 25,986 2 51,972
Automated processes--820.70(i)............... 25,986 1 25,986 8 207,888
Control of inspection, measuring, and test 25,986 1 25,986 5 129,930
equipment--820.72(a)........................
Calibration procedures, standards, and 25,986 1 25,986 1 25,986
records--820.72(b)(1) to (b)(2).............
Process validation--820.75(a)................ 25,986 1 25,986 3 77,958
Validated process parameters, monitoring, 25,986 1 25,986 1 25,986
control methods, and data--820.75(b)........
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Revalidation--820.75(c)...................... 25,986 1 25,986 1 25,986
Acceptance activities--820.80(a) to (e)...... 25,986 1 25,986 5 129,930
Acceptance status--820.86.................... 25,986 1 25,986 1 25,986
Control of nonconforming product--820.90(a).. 25,986 1 25,986 5 129,930
Nonconforming product review/disposition 25,986 1 25,986 5 129,930
procedures and rework procedures--
820.90(b)(1) to (b)(2)......................
Procedures for corrective/preventive actions-- 25,986 1 25,986 12 311,832
820.100(a)(1) to (a)(7).....................
Corrective/preventive activities--820.100(b). 25,986 1 25,986 1 25,986
Labeling procedures--820.120(b).............. 25,986 1 25,986 1 25,986
Labeling documentation--820.120(d)........... 25,986 1 25,986 1 25,986
Device packaging--820.130.................... 25,986 1 25,986 1 25,986
Handling--820.140............................ 25,986 1 25,986 6 155,916
Storage--820.150(a) and (b).................. 25,986 1 25,986 6 155,916
Distribution procedures and records-- 25,986 1 25,986 1 25,986
820.160(a) and (b)..........................
Installation--820.170........................ 25,986 1 25,986 2 51,972
Record retention period--820.180(b) and (c).. 25,986 1 25,986 2 51,972
Device master record--820.181................ 25,986 1 25,986 1 25,986
Device history record--820.184............... 25,986 1 25,986 1 25,986
Quality system record--820.186............... 25,986 1 25,986 1 25,986
Complaint files--820.198(a), (c), and (g).... 25,986 1 25,986 5 129,930
Servicing procedures and reports--820.200(a) 25,986 1 25,986 3 77,958
and (d).....................................
Statistical techniques procedures and 25,986 1 25,986 1 25,986
sampling plans--820.250.....................
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Total.................................... ....................... .............. ....................... .............. 9,043,128
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18351 Filed 7-30-13; 8:45 am]
BILLING CODE 4160-01-P