[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62144-62148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21553]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2544]


Agency Information Collection Activities; Proposed Collection; 
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 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 November 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 62145]]

     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the 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-2016-N-2544 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Device: Current Good 
Manufacturing Practice Quality System Regulations.''
    Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://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 information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 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

[[Page 62146]]

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 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

[[Page 62147]]

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 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 PRA burden placed on the 24,738 
establishments is an average burden.
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    \1\ Based on fiscal year 2015 data.

                               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 hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
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--               24,738               1          24,738              10         247,380
 820.20(e)......................
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).....

[[Page 62148]]

 
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            24,738               1          24,738               2          49,476
 and 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--                  24,738               1          24,738               2          49,476
 820.70(h)......................
Automated processes--820.70(i)..          24,738               1          24,738               8         197,904
Control of inspection,                    24,738               1          24,738               5         123,690
 measuring, and test equipment--
 820.72(a)......................
Calibration procedures,                   24,738               1          24,738               1          24,738
 standards, 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
Acceptance activities--820.80(a)-         24,738               1          24,738               5         123,690
 (e)............................
Acceptance status--820.86.......          24,738               1          24,738               1          24,738
Control of nonconforming                  24,738               1          24,738               5         123,690
 product--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/                24,738               1          24,738              12         296,856
 preventive actions--
 820.100(a)(1)-(a)(7)...........
Corrective/preventive                     24,738               1          24,738               1          24,738
 activities--820.100(b).........
Labeling procedures--820.120(b).          24,738               1          24,738               1          24,738
Labeling documentation--                  24,738               1          24,738               1          24,738
 820.120(d).....................
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               24,738               1          24,738               1          24,738
 records--820.160(a) and (b)....
Installation--820.170...........          24,738               1          24,738               2          49,476
Record retention period--                 24,738               1          24,738               2          49,476
 820.180(b) 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),              24,738               1          24,738               5         123,690
 (c), and (g)...................
Servicing procedures and                  24,738               1          24,738               3          74,214
 reports--820.200(a) and (d)....
Statistical techniques                    24,738               1          24,738               1          24,738
 procedures and sampling plans--
 820.250........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       8,410,920
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21553 Filed 9-7-16; 8:45 am]
 BILLING CODE 4164-01-P