[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

[[Page 46350]]

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)........

[[Page 46351]]

 
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