Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations, 87572-87575 [2016-29028]
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Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
the specific symbols used in labels or
labeling for the IVDs manufactured.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
Glossary .....................................................................
689
1
689
4
2,756
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
collection of information to OMB for
review and clearance.
Medical Device: Current Good
Manufacturing Practice Quality System
Regulations— OMB Control Number
0910–0073—Extension
[FR Doc. 2016–29104 Filed 12–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device:
Current Good Manufacturing Practice
Quality System Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 4,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0073. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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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 Current Good Manufacturing
Practice (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/Quality System (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
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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
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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
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
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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
the 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)
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87573
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, and 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
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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 § 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, re-labelers, and contract
sterilizer firms, which are subject only
to requirements applicable to their
activities. In addition, remanufacturers
of hospital single-use devices are now
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 24,738 respondents. A
query of the Agency’s registration and
listing database shows that
approximately 13,294 domestic and
11,444 foreign establishments are
respondents to this information
collection.1 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 (§ 820.20(a)), Document Control
(§ 820.40), and other requirements,
whereas only manufacturers and
specification developers are subject to
subpart C, Design Controls. The
Paperwork Reduction Act burden
placed on the 24,738 establishments is
an average burden.
In the Federal Register of September
8, 2016 (81 FR 62144), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
sradovich on DSK3GMQ082PROD with NOTICES
Activity/21 CFR section
Quality policy—820.20(a) ...........................................................
Organization—820.20(b) ............................................................
Management review—820.20(c) ................................................
Quality planning—820.20(d) ......................................................
Quality system procedures—820.20(e) .....................................
Quality audit—820.22 ................................................................
Training—820.25(b) ...................................................................
Design procedures—820.30(a)(1) .............................................
Design and development planning—820.30(b) .........................
Design input—820.30(c) ............................................................
Design output—820.30(d) ..........................................................
Design review—820.30(e) .........................................................
Design verification—820.30(f) ....................................................
Design validation—820.30(g) .....................................................
Design transfer—820.30(h) ........................................................
Design changes—820.30(i) .......................................................
Design history file—820.30(j) .....................................................
Document controls—820.40 ......................................................
Documentation approval and distribution and document
changes—820.40(a) and (b) ..................................................
Purchasing controls—820.50(a) ................................................
Purchasing data—820.50(b) ......................................................
Identification—820.60 ................................................................
Traceability—820.65 ..................................................................
Production and process controls—820.70(a) ............................
Production and process changes and environmental control—
820.70(b) and (c) ....................................................................
Personnel—820.70(d) ................................................................
Contamination control—820.70(e) .............................................
Equipment maintenance schedule, inspection, and adjustment—820.70(g)(1)–(g)(3) .....................................................
Manufacturing material—820.70(h) ...........................................
Automated processes—820.70(i) ..............................................
Control of inspection, measuring, and test equipment—
820.72(a) ................................................................................
Calibration
procedures,
standards,
and
records—
820.72(b)(1)–(b)(2) .................................................................
Process validation—820.75(a) ...................................................
Validated process parameters, monitoring, control methods,
and data—820.75(b) ..............................................................
Revalidation—820.75(c) .............................................................
1 Based
Number of
records per
recordkeeper
Total annual
records
19:12 Dec 02, 2016
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Frm 00045
Total hours
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
7
4
6
10
10
33
13
2
6
2
2
23
37
37
3
17
3
9
173,166
98,952
148,428
247,380
247,380
816,354
321,594
49,476
148,428
49,476
49,476
568,974
915,306
915,306
74,214
420,546
74,214
222,642
24,738
24,738
24,738
24,738
24,738
24,738
1
1
1
1
1
1
24,738
24,738
24,738
24,738
24,738
24,738
2
22
6
1
1
2
49,476
544,236
148,428
24,738
24,738
49,476
24,738
24,738
24,738
1
1
1
24,738
24,738
24,738
2
3
2
49,476
74,214
49,476
24,738
24,738
24,738
1
1
1
24,738
24,738
24,738
1
2
8
24,738
49,476
197,904
24,738
1
24,738
5
123,690
24,738
24,738
1
1
24,738
24,738
1
3
24,738
74,214
24,738
24,738
1
1
24,738
24,738
1
1
24,738
24,738
on fiscal year 2015 data.
VerDate Sep<11>2014
Average
burden per
recordkeeping
Fmt 4703
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Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Acceptance activities—820.80(a)–(e) ........................................
Acceptance status—820.86 .......................................................
Control of nonconforming product—820.90(a) ..........................
Nonconforming product review/disposition procedures and rework procedures—820.90(b)(1)–(b)(2) ...................................
Procedures for corrective/preventive actions—820.100(a)(1)–
(a)(7) .......................................................................................
Corrective/preventive activities—820.100(b) .............................
Labeling procedures—820.120(b) .............................................
Labeling documentation—820.120(d) ........................................
Device packaging—820.130 ......................................................
Handling—820.140 ....................................................................
Storage—820.150(a) and (b) .....................................................
Distribution procedures and records—820.160(a) and (b) ........
Installation—820.170 .................................................................
Record retention period—820.180(b) and (c) ............................
Device master record—820.181 ................................................
Device history record—820.184 ................................................
Quality system record—820.186 ...............................................
Complaint files—820.198(a), (c), and (g) ..................................
Servicing procedures and reports—820.200(a) and (d) ............
Statistical techniques procedures and sampling plans—
820.250 ...................................................................................
Total ....................................................................................
1 There
Number of
records per
recordkeeper
Number of
recordkeepers
Activity/21 CFR section
1
1
1
24,738
24,738
24,738
5
1
5
123,690
24,738
123,690
24,738
1
24,738
5
123,690
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
12
1
1
1
1
6
6
1
2
2
1
1
1
5
3
296,856
24,738
24,738
24,738
24,738
148,428
148,428
24,738
49,476
49,476
24,738
24,738
24,738
123,690
74,214
24,738
1
24,738
1
24,738
........................
........................
........................
........................
8,608,824
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2013–D–0117]
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
[FR Doc. 2016–29028 Filed 12–2–16; 8:45 am]
BILLING CODE 4160–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Providing
Information About Pediatric Uses of
Medical Devices
Food and Drug Administration,
HHS.
Notice.
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
the information collection regarding
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
Total hours
24,738
24,738
24,738
‘‘Providing Information About Pediatric
Uses of Medical Devices Under Section
515A of the Federal Food, Drug, and
Cosmetic Act.’’
DATES: Submit either electronic or
written comments on the collection of
information by February 3, 2017.
ADDRESSES: You may submit comments
as follows:
ACTION:
Average
burden per
recordkeeping
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Total annual
records
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19:12 Dec 02, 2016
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public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–0117 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Providing
Information About Pediatric Uses of
Medical Devices.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
E:\FR\FM\05DEN1.SGM
05DEN1
]]>Agencies
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87572-87575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29028]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2544]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device:
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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
4, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0073.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device: Current Good Manufacturing Practice Quality System
Regulations-- 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 Current Good
Manufacturing Practice (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/Quality System (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
[[Page 87573]]
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 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 the 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, and 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
[[Page 87574]]
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) re-packer, re-
labelers, and contract sterilizer firms, which are subject only to
requirements applicable to their activities. In addition,
remanufacturers of hospital single-use devices are now 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 24,738 respondents.
A query of the Agency's registration and listing database shows that
approximately 13,294 domestic and 11,444 foreign establishments are
respondents to this information collection.\1\ 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 Paperwork Reduction Act burden placed
on the 24,738 establishments is an average burden.
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\1\ Based on fiscal year 2015 data.
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In the Federal Register of September 8, 2016 (81 FR 62144), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 records per Total annual per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
Quality policy--820.20(a)........... 24,738 1 24,738 7 173,166
Organization--820.20(b)............. 24,738 1 24,738 4 98,952
Management review--820.20(c)........ 24,738 1 24,738 6 148,428
Quality planning--820.20(d)......... 24,738 1 24,738 10 247,380
Quality system procedures--820.20(e) 24,738 1 24,738 10 247,380
Quality audit--820.22............... 24,738 1 24,738 33 816,354
Training--820.25(b)................. 24,738 1 24,738 13 321,594
Design procedures--820.30(a)(1)..... 24,738 1 24,738 2 49,476
Design and development planning-- 24,738 1 24,738 6 148,428
820.30(b)..........................
Design input--820.30(c)............. 24,738 1 24,738 2 49,476
Design output--820.30(d)............ 24,738 1 24,738 2 49,476
Design review--820.30(e)............ 24,738 1 24,738 23 568,974
Design verification--820.30(f)...... 24,738 1 24,738 37 915,306
Design validation--820.30(g)........ 24,738 1 24,738 37 915,306
Design transfer--820.30(h).......... 24,738 1 24,738 3 74,214
Design changes--820.30(i)........... 24,738 1 24,738 17 420,546
Design history file--820.30(j)...... 24,738 1 24,738 3 74,214
Document controls--820.40........... 24,738 1 24,738 9 222,642
Documentation approval and 24,738 1 24,738 2 49,476
distribution and document changes--
820.40(a) and (b)..................
Purchasing controls--820.50(a)...... 24,738 1 24,738 22 544,236
Purchasing data--820.50(b).......... 24,738 1 24,738 6 148,428
Identification--820.60.............. 24,738 1 24,738 1 24,738
Traceability--820.65................ 24,738 1 24,738 1 24,738
Production and process controls-- 24,738 1 24,738 2 49,476
820.70(a)..........................
Production and process changes and 24,738 1 24,738 2 49,476
environmental control--820.70(b)
and (c)............................
Personnel--820.70(d)................ 24,738 1 24,738 3 74,214
Contamination control--820.70(e).... 24,738 1 24,738 2 49,476
Equipment maintenance schedule, 24,738 1 24,738 1 24,738
inspection, and adjustment--
820.70(g)(1)-(g)(3)................
Manufacturing material--820.70(h)... 24,738 1 24,738 2 49,476
Automated processes--820.70(i)...... 24,738 1 24,738 8 197,904
Control of inspection, measuring, 24,738 1 24,738 5 123,690
and test equipment--820.72(a)......
Calibration procedures, standards, 24,738 1 24,738 1 24,738
and records--820.72(b)(1)-(b)(2)...
Process validation--820.75(a)....... 24,738 1 24,738 3 74,214
Validated process parameters, 24,738 1 24,738 1 24,738
monitoring, control methods, and
data--820.75(b)....................
Revalidation--820.75(c)............. 24,738 1 24,738 1 24,738
[[Page 87575]]
Acceptance activities--820.80(a)-(e) 24,738 1 24,738 5 123,690
Acceptance status--820.86........... 24,738 1 24,738 1 24,738
Control of nonconforming product-- 24,738 1 24,738 5 123,690
820.90(a)..........................
Nonconforming product review/ 24,738 1 24,738 5 123,690
disposition procedures and rework
procedures--820.90(b)(1)-(b)(2)....
Procedures for corrective/preventive 24,738 1 24,738 12 296,856
actions--820.100(a)(1)-(a)(7)......
Corrective/preventive activities-- 24,738 1 24,738 1 24,738
820.100(b).........................
Labeling procedures--820.120(b)..... 24,738 1 24,738 1 24,738
Labeling documentation--820.120(d).. 24,738 1 24,738 1 24,738
Device packaging--820.130........... 24,738 1 24,738 1 24,738
Handling--820.140................... 24,738 1 24,738 6 148,428
Storage--820.150(a) and (b)......... 24,738 1 24,738 6 148,428
Distribution procedures and records-- 24,738 1 24,738 1 24,738
820.160(a) and (b).................
Installation--820.170............... 24,738 1 24,738 2 49,476
Record retention period--820.180(b) 24,738 1 24,738 2 49,476
and (c)............................
Device master record--820.181....... 24,738 1 24,738 1 24,738
Device history record--820.184...... 24,738 1 24,738 1 24,738
Quality system record--820.186...... 24,738 1 24,738 1 24,738
Complaint files--820.198(a), (c), 24,738 1 24,738 5 123,690
and (g)............................
Servicing procedures and reports-- 24,738 1 24,738 3 74,214
820.200(a) and (d).................
Statistical techniques procedures 24,738 1 24,738 1 24,738
and sampling plans--820.250........
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Total........................... .............. .............. .............. .............. 8,608,824
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: November 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29028 Filed 12-2-16; 8:45 am]
BILLING CODE 4160-01-P
