[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 [email protected]. 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, [email protected].

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
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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
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\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