[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37317-37321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16260]


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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 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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 30, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    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 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):Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for

[[Page 37318]]

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 Devices; Current Good 
Manufacturing Practice Quality System Regulation.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 
(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 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

[[Page 37319]]

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 (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 (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 (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 (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, 
examination/release for storage and use, and to 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 (g) 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

[[Page 37320]]

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 27,074 respondents. 
This estimate is based on a query of the Agency's registration and 
listing database. Respondents to this information 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 27,074 establishments is 
an average burden.
    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
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Quality policy--820.20(a).......          27,074               1          27,074               7         189,518
Organization--820.20(b).........          27,074               1          27,074               4         108,296
Management review--820.20(c)....          27,074               1          27,074               6         162,444
Quality planning--820.20(d).....          27,074               1          27,074              10         270,740
Quality system procedures--               27,074               1          27,074              10         270,740
 820.20(e)......................
Quality audit--820.22...........          27,074               1          27,074              33         893,442
Training--820.25(b).............          27,074               1          27,074              13         351,962
Design procedures--820.30(a)(1).          27,074               1          27,074               2          54,148
Design and development planning--         27,074               1          27,074               6         162,444
 820.30(b)......................
Design input--820.30(c).........          27,074               1          27,074               2          54,148
Design output--820.30(d)........          27,074               1          27,074               2          54,148
Design review--820.30(e)........          27,074               1          27,074              23         622,702
Design verification--820.30(f)..          27,074               1          27,074              37       1,001,738
Design validation--820.30(g)....          27,074               1          27,074              37       1,001,738
Design transfer--820.30(h)......          27,074               1          27,074               3          81,222
Design changes--820.30(i).......          27,074               1          27,074              17         460,258
Design history file--820.30(j)..          27,074               1          27,074               3          81,222
Document controls--820.40.......          27,074               1          27,074               9         243,666
Documentation approval and                27,074               1          27,074               2          54,148
 distribution and document
 changes--820.40(a) and (b).....
Purchasing controls--820.50(a)..          27,074               1          27,074              22         595,628
Purchasing data--820.50(b)......          27,074               1          27,074               6         162,444
Identification--820.60..........          27,074               1          27,074               1          27,074
Traceability--820.65............          27,074               1          27,074               1          27,074
Production and process controls--         27,074               1          27,074               2          54,148
 820.70(a)......................
Production and process changes            27,074               1          27,074               2          54,148
 and environmental control--
 820.70(b) and (c)..............
Personnel--820.70(d)............          27,074               1          27,074               3          81,222
Contamination control--820.70(e)          27,074               1          27,074               2          54,148
Equipment maintenance schedule,           27,074               1          27,074               1          27,074
 inspection, and adjustment--
 820.70(g)(1)-(3)...............
Manufacturing material--                  27,074               1          27,074               2          54,148
 820.70(h)......................
Automated processes--820.70(i)..          27,074               1          27,074               8         216,592
Control of inspection,                    27,074               1          27,074               5         135,370
 measuring, and test equipment--
 820.72(a)......................
Calibration procedures,                   27,074               1          27,074               1          27,074
 standards, and records--
 820.72(b)(1)-(2)...............
Process validation--820.75(a)...          27,074               1          27,074               3          81,222

[[Page 37321]]

 
Validated process parameters,             27,074               1          27,074               1          27,074
 monitoring, control methods,
 and data--820.75(b)............
Revalidation--820.75(c).........          27,074               1          27,074               1          27,074
Acceptance activities--820.80(a)-         27,074               1          27,074               5         135,370
 (e)............................
Acceptance status--820.86.......          27,074               1          27,074               1          27,074
Control of nonconforming                  27,074               1          27,074               5         135,370
 product--820.90(a).............
Nonconforming product review/             27,074               1          27,074               5         135,370
 disposition procedures and
 rework procedures--820.90(b)(1)-
 (2)............................
Procedures for corrective/                27,074               1          27,074              12         324,888
 preventive actions--
 820.100(a)(1)-(7)..............
Corrective/preventive                     27,074               1          27,074               1          27,074
 activities--820.100(b).........
Labeling procedures--820.120(b).          27,074               1          27,074               1          27,074
Labeling documentation--                  27,074               1          27,074               1          27,074
 820.120(d).....................
Device packaging--820.130.......          27,074               1          27,074               1          27,074
Handling--820.140...............          27,074               1          27,074               6         162,444
Storage--820.150(a) and (b).....          27,074               1          27,074               6         162,444
Distribution procedures and               27,074               1          27,074               1          27,074
 records--820.160(a) and (b)....
Installation--820.170...........          27,074               1          27,074               2          54,148
Record retention period--                 27,074               1          27,074               2          54,148
 820.180(b) and (c).............
Device master record--820.181...          27,074               1          27,074               1          27,074
Device history record--820.184..          27,074               1          27,074               1          27,074
Quality system record--820.186..          27,074               1          27,074               1          27,074
Complaint files--820.198(a)-(g).          27,074               1          27,074               5         135,370
Servicing procedures and                  27,074               1          27,074               3          81,222
 reports--820.200(a) and (d)....
Statistical techniques                    27,074               1          27,074               1          27,074
 procedures and sampling plans--
 820.250........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       9,421,752
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase of 812,928 hours. We attribute this adjustment to an 
increase in the number of respondents.

    Dated: July 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16260 Filed 7-30-19; 8:45 am]
BILLING CODE 4164-01-P