Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations, 87572-87575 [2016-29028]

Download as PDF 87572 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices the specific symbols used in labels or labeling for the IVDs manufactured. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Glossary ..................................................................... 689 1 689 4 2,756 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 30, 2016. Leslie Kux, Associate Commissioner for Policy. collection of information to OMB for review and clearance. Medical Device: Current Good Manufacturing Practice Quality System Regulations— OMB Control Number 0910–0073—Extension [FR Doc. 2016–29104 Filed 12–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2544] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 4, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0073. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Model for Quality Assurance in Design/ Development, Production, Installation, and Servicing.’’ The CGMP/QS information collections will assist FDA inspections of manufacturers for compliance with QS requirements encompassing design, production, installation, and servicing processes. Section 820.20(a) through (e) requires management with executive responsibility to establish, maintain, and/or review the following topics: (1) The quality policy, (2) the organizational structure, (3) the quality plan, and (4) the quality system procedures of the organization. Section 820.22 requires the conduct and documentation of QS audits and reaudits. Section 820.25(b) requires the establishment of procedures to identify training needs and documentation of such training. Section 820.30(a)(1) and (b) through (j) requires, in respective order, the establishment, maintenance, and/or documentation of the following topics: (1) Procedures to control design of class III and class II devices and certain class I devices as listed therein; (2) plans for design and development activities and updates; (3) procedures identifying, documenting, and approving design input requirements; (4) procedures defining design output, including acceptance criteria, and documentation of approved records; (5) procedures for formal review of design results and documentation of results in the design history file (DHF); (6) procedures for verifying device design and documentation of results and approvals in the DHF; (7) procedures for validating device design, including documentation of results in the DHF; (8) procedures for translating device design into production specifications; (9) procedures for documenting, verifying, and validating approved design changes before implementation of changes; and (10) the records and references constituting the DHF for each type of device. Section 820.40 requires manufacturers to establish and maintain procedures controlling approval and distribution of required documents and document E:\FR\FM\05DEN1.SGM 05DEN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 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 VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 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) PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 87573 procedures controlling the release of products for distribution; (5) distribution records that identify consignee, product, date, and control numbers; and (6) instructions, inspection and test procedures that are made available, and the recording of results for devices requiring installation. Sections 820.180(b) and (c); 820.181(a) through (e); 820.184(a) through (f); and 820.186 require, respectively, the maintenance of records that are: (1) Retained at prescribed site(s), made readily available and accessible to FDA, and retained for the device’s life expectancy or for 2 years; (2) contained or referenced in a DMR consisting of device, process, quality assurance, packaging and labeling, and installation, maintenance, and servicing specifications and procedures; (3) contained in a DHR and demonstrate the manufacture of each unit, lot, or batch of product in conformance with DMR and regulatory requirements include manufacturing and distribution dates, quantities, acceptance documents, labels and labeling, and control numbers; and (4) contained in a quality system record, consisting of references, documents, procedures, and activities not specific to particular devices. Sections 820.198(a) through (c); and 820.200(a) through (d), respectively, require the establishment, maintenance, and/or documentation of the following topics: (1) Complaint files and procedures for receiving, reviewing, and evaluating complaints; (2) complaint investigation records identifying the device, complainant, and relationship of the device to the incident; (3) complaint records that are reasonably accessible to the manufacturing site or at prescribed sites; (4) procedures for performing and verifying that device servicing requirements are met and that service reports involving complaints are processed as complaints; and (5) service reports that record the device, service activity, and test and inspection data. Section 820.250 requires the establishment and maintenance of procedures to identify valid statistical techniques necessary to verify process and product acceptability; and sampling plans, when used, which are written and based on valid statistical rationale; and procedures for ensuring adequate sampling methods. The CGMP/QS regulation added design and purchasing controls, modified previous critical device requirements, revised previous validation and other requirements, and harmonized device CGMP requirements with QS specifications in the international standard ‘‘ISO 9001: Quality Systems Model for Quality E:\FR\FM\05DEN1.SGM 05DEN1 87574 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices Assurance in Design/Development, Production, Installation, and Servicing.’’ The rule does not apply to manufacturers of components or parts of finished devices, or to manufacturers of human blood and blood components subject to 21 CFR part 606. With respect to devices classified in class I, design control requirements apply only to class I devices listed in § 820.30(a)(2) of the regulation. The rule imposes burden upon: (1) Finished device manufacturer firms, which are subject to all recordkeeping requirements; (2) finished device contract manufacturers, specification developers; and (3) repacker, re-labelers, and contract sterilizer firms, which are subject only to requirements applicable to their activities. In addition, remanufacturers of hospital single-use devices are now considered to have the same requirements as manufacturers in regard to the regulation. The establishment, maintenance, and/ or documentation of procedures, records, and data required by the regulation assists FDA in determining whether firms are in compliance with CGMP requirements, which are intended to ensure that devices meet their design, production, labeling, installation, and servicing specifications and, thus are safe, effective, and suitable for their intended purpose. In particular, compliance with CGMP design control requirements should decrease the number of design-related device failures that have resulted in deaths and serious injuries. The CGMP/QS regulation applies to approximately 24,738 respondents. A query of the Agency’s registration and listing database shows that approximately 13,294 domestic and 11,444 foreign establishments are respondents to this information collection.1 Respondents to this collection have no reporting activities, but must make required records available for review or copying during FDA inspection. Except for manufacturers, not every type of firm is subject to every CGMP/QS requirement. For example, all are subject to Quality Policy (§ 820.20(a)), Document Control (§ 820.40), and other requirements, whereas only manufacturers and specification developers are subject to subpart C, Design Controls. The Paperwork Reduction Act burden placed on the 24,738 establishments is an average burden. In the Federal Register of September 8, 2016 (81 FR 62144), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers sradovich on DSK3GMQ082PROD with NOTICES Activity/21 CFR section Quality policy—820.20(a) ........................................................... Organization—820.20(b) ............................................................ Management review—820.20(c) ................................................ Quality planning—820.20(d) ...................................................... Quality system procedures—820.20(e) ..................................... Quality audit—820.22 ................................................................ Training—820.25(b) ................................................................... Design procedures—820.30(a)(1) ............................................. Design and development planning—820.30(b) ......................... Design input—820.30(c) ............................................................ Design output—820.30(d) .......................................................... Design review—820.30(e) ......................................................... Design verification—820.30(f) .................................................... Design validation—820.30(g) ..................................................... Design transfer—820.30(h) ........................................................ Design changes—820.30(i) ....................................................... Design history file—820.30(j) ..................................................... Document controls—820.40 ...................................................... Documentation approval and distribution and document changes—820.40(a) and (b) .................................................. Purchasing controls—820.50(a) ................................................ Purchasing data—820.50(b) ...................................................... Identification—820.60 ................................................................ Traceability—820.65 .................................................................. Production and process controls—820.70(a) ............................ Production and process changes and environmental control— 820.70(b) and (c) .................................................................... Personnel—820.70(d) ................................................................ Contamination control—820.70(e) ............................................. Equipment maintenance schedule, inspection, and adjustment—820.70(g)(1)–(g)(3) ..................................................... Manufacturing material—820.70(h) ........................................... Automated processes—820.70(i) .............................................. Control of inspection, measuring, and test equipment— 820.72(a) ................................................................................ Calibration procedures, standards, and records— 820.72(b)(1)–(b)(2) ................................................................. Process validation—820.75(a) ................................................... Validated process parameters, monitoring, control methods, and data—820.75(b) .............................................................. Revalidation—820.75(c) ............................................................. 1 Based Number of records per recordkeeper Total annual records 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00045 Total hours 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 7 4 6 10 10 33 13 2 6 2 2 23 37 37 3 17 3 9 173,166 98,952 148,428 247,380 247,380 816,354 321,594 49,476 148,428 49,476 49,476 568,974 915,306 915,306 74,214 420,546 74,214 222,642 24,738 24,738 24,738 24,738 24,738 24,738 1 1 1 1 1 1 24,738 24,738 24,738 24,738 24,738 24,738 2 22 6 1 1 2 49,476 544,236 148,428 24,738 24,738 49,476 24,738 24,738 24,738 1 1 1 24,738 24,738 24,738 2 3 2 49,476 74,214 49,476 24,738 24,738 24,738 1 1 1 24,738 24,738 24,738 1 2 8 24,738 49,476 197,904 24,738 1 24,738 5 123,690 24,738 24,738 1 1 24,738 24,738 1 3 24,738 74,214 24,738 24,738 1 1 24,738 24,738 1 1 24,738 24,738 on fiscal year 2015 data. VerDate Sep<11>2014 Average burden per recordkeeping Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1 87575 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Acceptance activities—820.80(a)–(e) ........................................ Acceptance status—820.86 ....................................................... Control of nonconforming product—820.90(a) .......................... Nonconforming product review/disposition procedures and rework procedures—820.90(b)(1)–(b)(2) ................................... Procedures for corrective/preventive actions—820.100(a)(1)– (a)(7) ....................................................................................... Corrective/preventive activities—820.100(b) ............................. Labeling procedures—820.120(b) ............................................. Labeling documentation—820.120(d) ........................................ Device packaging—820.130 ...................................................... Handling—820.140 .................................................................... Storage—820.150(a) and (b) ..................................................... Distribution procedures and records—820.160(a) and (b) ........ Installation—820.170 ................................................................. Record retention period—820.180(b) and (c) ............................ Device master record—820.181 ................................................ Device history record—820.184 ................................................ Quality system record—820.186 ............................................... Complaint files—820.198(a), (c), and (g) .................................. Servicing procedures and reports—820.200(a) and (d) ............ Statistical techniques procedures and sampling plans— 820.250 ................................................................................... Total .................................................................................... 1 There Number of records per recordkeeper Number of recordkeepers Activity/21 CFR section 1 1 1 24,738 24,738 24,738 5 1 5 123,690 24,738 123,690 24,738 1 24,738 5 123,690 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 12 1 1 1 1 6 6 1 2 2 1 1 1 5 3 296,856 24,738 24,738 24,738 24,738 148,428 148,428 24,738 49,476 49,476 24,738 24,738 24,738 123,690 74,214 24,738 1 24,738 1 24,738 ........................ ........................ ........................ ........................ 8,608,824 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Electronic Submissions [Docket No. FDA–2013–D–0117] Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the [FR Doc. 2016–29028 Filed 12–2–16; 8:45 am] BILLING CODE 4160–01–P Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Information About Pediatric Uses of Medical Devices Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection regarding SUMMARY: sradovich on DSK3GMQ082PROD with NOTICES Total hours 24,738 24,738 24,738 ‘‘Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.’’ DATES: Submit either electronic or written comments on the collection of information by February 3, 2017. ADDRESSES: You may submit comments as follows: ACTION: Average burden per recordkeeping are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 28, 2016. Leslie Kux, Associate Commissioner for Policy. AGENCY: Total annual records VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2013–D–0117 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Information About Pediatric Uses of Medical Devices.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential E:\FR\FM\05DEN1.SGM 05DEN1

Agencies

[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87572-87575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device: 
Current Good Manufacturing Practice Quality System Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
4, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0073. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device: Current Good Manufacturing Practice Quality System 
Regulations-- OMB Control Number 0910-0073--Extension

    Under section 520(f) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the Department of 
Health and Human Services has the authority to prescribe regulations 
requiring that the methods used in, and the facilities and controls 
used for, the manufacture, preproduction design validation (including a 
process to assess the performance of a device, but not including an 
evaluation of the safety and effectiveness of a device), packing, 
storage, and installation of a device conform to Current Good 
Manufacturing Practice (CGMP), as described in such regulations, to 
assure that the device will be safe and effective and otherwise in 
compliance with the FD&C Act.
    The CGMP/Quality System (QS) regulation implementing authority 
provided by this statutory provision is found under part 820 (21 CFR 
part 820) and sets forth basic CGMP requirements governing the design, 
manufacture, packing, labeling, storage, installation, and servicing of 
all finished medical devices intended for human use. The authority for 
this regulation is covered under sections 501, 502, 510, 513, 514, 515, 
518, 519, 520, 522, 701, 704, 801, and 803 of the FD&C Act (21 U.S.C. 
351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 
and 383). The CGMP/QS regulation includes requirements for purchasing 
and service controls, clarifies recordkeeping requirements for device 
failure and complaint investigations, clarifies requirements for 
verifying/validating production processes and process or product 
changes, and clarifies requirements for product acceptance activities 
quality data evaluations and corrections of nonconforming product/
quality problems.
    Requirements are compatible with specifications in the 
international standards ``ISO 9001: Quality Systems Model for Quality 
Assurance in Design/Development, Production, Installation, and 
Servicing.'' The CGMP/QS information collections will assist FDA 
inspections of manufacturers for compliance with QS requirements 
encompassing design, production, installation, and servicing processes.
    Section 820.20(a) through (e) requires management with executive 
responsibility to establish, maintain, and/or review the following 
topics: (1) The quality policy, (2) the organizational structure, (3) 
the quality plan, and (4) the quality system procedures of the 
organization. Section 820.22 requires the conduct and documentation of 
QS audits and re-audits. Section 820.25(b) requires the establishment 
of procedures to identify training needs and documentation of such 
training.
    Section 820.30(a)(1) and (b) through (j) requires, in respective 
order, the establishment, maintenance, and/or documentation of the 
following topics: (1) Procedures to control design of class III and 
class II devices and certain class I devices as listed therein; (2) 
plans for design and development activities and updates; (3) procedures 
identifying, documenting, and approving design input requirements; (4) 
procedures defining design output, including acceptance criteria, and 
documentation of approved records; (5) procedures for formal review of 
design results and documentation of results in the design history file 
(DHF); (6) procedures for verifying device design and documentation of 
results and approvals in the DHF; (7) procedures for validating device 
design, including documentation of results in the DHF; (8) procedures 
for translating device design into production specifications; (9) 
procedures for documenting, verifying, and validating approved design 
changes before implementation of changes; and (10) the records and 
references constituting the DHF for each type of device.
    Section 820.40 requires manufacturers to establish and maintain 
procedures controlling approval and distribution of required documents 
and document

[[Page 87573]]

changes. Section 820.40(a) and (b) requires the establishment and 
maintenance of procedures for the review, approval, issuance, and 
documentation of required records (documents) and changes to those 
records.
    Section 820.50(a) and (b) requires the establishment and 
maintenance of procedures and requirements to ensure service and 
product quality, records of acceptable suppliers, and purchasing data 
describing specified requirements for products and services.
    Sections 820.60 and 820.65 require, respectively, the establishment 
and maintenance of procedures for identifying all products from receipt 
to distribution and for using control numbers to track surgical 
implants and life-sustaining or supporting devices and their 
components.
    Section 820.70(a) through (e), (g)(1) through (g)(3), (h), and (i) 
requires the establishment, maintenance, and/or documentation of the 
following topics: (1) Process control procedures; (2) procedures for 
verifying or validating changes to specification, method, process, or 
procedure; (3) procedures to control environmental conditions and 
inspection result records; (4) requirements for personnel hygiene; (5) 
procedures for preventing contamination of equipment and products; (6) 
equipment adjustment, cleaning, and maintenance schedules; (7) 
equipment inspection records; (8) equipment tolerance postings, 
procedures for utilizing manufacturing materials expected to have an 
adverse effect on product quality; and (9) validation protocols and 
validation records for computer software and software changes.
    Sections 820.72(a), (b)(1), and (b)(2); and 820.75(a) through (c) 
require, respectively, the establishment, maintenance, and/or 
documentation of the following topics: (1) Equipment calibration and 
inspection procedures; (2) national, international, or in-house 
calibration standards; (3) records that identify calibrated equipment 
and next calibration dates; (4) validation procedures and validation 
results for processes not verifiable by inspections and tests; (5) 
procedures for keeping validated processes within specified limits; (6) 
records for monitoring and controlling validated processes; and (7) 
records of the results of revalidation where necessitated by process 
changes or deviations.
    Sections 820.80(a) through (e) and 820.86, respectively, require 
the establishment, maintenance, and/or documentation of the following 
topics: (1) Procedures for incoming acceptance by inspection, test, or 
other verification; (2) procedures for ensuring that in process 
products meet specified requirements and the control of product until 
inspection and tests are completed; (3) procedures for, and records 
that show, incoming acceptance or rejection is conducted by 
inspections, tests or other verifications; (4) procedures for, and 
records that show, finished devices meet acceptance criteria and are 
not distributed until device master record (DMR) activities are 
completed; (5) records in the device history record (DHR) showing 
acceptance dates, results, and equipment used; and (6) the acceptance/
rejection identification of products from receipt to installation and 
servicing.
    Sections 820.90(a), (b)(1), and (b)(2) and 820.100 require, 
respectively, the establishment, maintenance and/or documentation of 
the following topics: (1) Procedures for identifying, recording, 
evaluating, and disposing of nonconforming product; (2) procedures for 
reviewing and recording concessions made for, and disposition of, 
nonconforming product; (3) procedures for reworking products, 
evaluating possible adverse rework effect and recording results in the 
DHR; (4) procedures and requirements for corrective and preventive 
actions, including analysis, investigation, identification and review 
of data, records, causes, and results; and (5) records for all 
corrective and preventive action activities.
    Section 820.100(a)(1) through (a)(7) states that procedures and 
requirements shall be established and maintained for corrective/
preventive actions, including the following: (1) Analysis of data from 
process, work, quality, servicing records, investigation of 
nonconformance causes; (2) identification of corrections and their 
effectiveness; (3) recording of changes made; and (4) appropriate 
distribution and managerial review of corrective and preventive action 
information. Section 820.120 states that manufacturers shall establish/
maintain procedures to control labeling storage/application; and 
examination/release for storage and use, and document those procedures.
    Sections 820.120(b) and (d); 820.130; 820.140; 820.150(a) and (b); 
820.160(a) and (b); and 820.170(a) and (b), respectively, require the 
establishment, maintenance, and/or documentation of the following 
topics: (1) Procedures for controlling and recording the storage, 
examination, release, and use of labeling; (2) the filing of labels/
labeling used in the DHR; (3) procedures for controlling product 
storage areas and receipt/dispatch authorizations; (4) procedures 
controlling the release of products for distribution; (5) distribution 
records that identify consignee, product, date, and control numbers; 
and (6) instructions, inspection and test procedures that are made 
available, and the recording of results for devices requiring 
installation.
    Sections 820.180(b) and (c); 820.181(a) through (e); 820.184(a) 
through (f); and 820.186 require, respectively, the maintenance of 
records that are: (1) Retained at prescribed site(s), made readily 
available and accessible to FDA, and retained for the device's life 
expectancy or for 2 years; (2) contained or referenced in a DMR 
consisting of device, process, quality assurance, packaging and 
labeling, and installation, maintenance, and servicing specifications 
and procedures; (3) contained in a DHR and demonstrate the manufacture 
of each unit, lot, or batch of product in conformance with DMR and 
regulatory requirements include manufacturing and distribution dates, 
quantities, acceptance documents, labels and labeling, and control 
numbers; and (4) contained in a quality system record, consisting of 
references, documents, procedures, and activities not specific to 
particular devices.
    Sections 820.198(a) through (c); and 820.200(a) through (d), 
respectively, require the establishment, maintenance, and/or 
documentation of the following topics: (1) Complaint files and 
procedures for receiving, reviewing, and evaluating complaints; (2) 
complaint investigation records identifying the device, complainant, 
and relationship of the device to the incident; (3) complaint records 
that are reasonably accessible to the manufacturing site or at 
prescribed sites; (4) procedures for performing and verifying that 
device servicing requirements are met and that service reports 
involving complaints are processed as complaints; and (5) service 
reports that record the device, service activity, and test and 
inspection data.
    Section 820.250 requires the establishment and maintenance of 
procedures to identify valid statistical techniques necessary to verify 
process and product acceptability; and sampling plans, when used, which 
are written and based on valid statistical rationale; and procedures 
for ensuring adequate sampling methods.
    The CGMP/QS regulation added design and purchasing controls, 
modified previous critical device requirements, revised previous 
validation and other requirements, and harmonized device CGMP 
requirements with QS specifications in the international standard ``ISO 
9001: Quality Systems Model for Quality

[[Page 87574]]

Assurance in Design/Development, Production, Installation, and 
Servicing.'' The rule does not apply to manufacturers of components or 
parts of finished devices, or to manufacturers of human blood and blood 
components subject to 21 CFR part 606. With respect to devices 
classified in class I, design control requirements apply only to class 
I devices listed in Sec.  820.30(a)(2) of the regulation. The rule 
imposes burden upon: (1) Finished device manufacturer firms, which are 
subject to all recordkeeping requirements; (2) finished device contract 
manufacturers, specification developers; and (3) re-packer, re-
labelers, and contract sterilizer firms, which are subject only to 
requirements applicable to their activities. In addition, 
remanufacturers of hospital single-use devices are now considered to 
have the same requirements as manufacturers in regard to the 
regulation.
    The establishment, maintenance, and/or documentation of procedures, 
records, and data required by the regulation assists FDA in determining 
whether firms are in compliance with CGMP requirements, which are 
intended to ensure that devices meet their design, production, 
labeling, installation, and servicing specifications and, thus are 
safe, effective, and suitable for their intended purpose. In 
particular, compliance with CGMP design control requirements should 
decrease the number of design-related device failures that have 
resulted in deaths and serious injuries.
    The CGMP/QS regulation applies to approximately 24,738 respondents. 
A query of the Agency's registration and listing database shows that 
approximately 13,294 domestic and 11,444 foreign establishments are 
respondents to this information collection.\1\ Respondents to this 
collection have no reporting activities, but must make required records 
available for review or copying during FDA inspection. Except for 
manufacturers, not every type of firm is subject to every CGMP/QS 
requirement. For example, all are subject to Quality Policy (Sec.  
820.20(a)), Document Control (Sec.  820.40), and other requirements, 
whereas only manufacturers and specification developers are subject to 
subpart C, Design Controls. The Paperwork Reduction Act burden placed 
on the 24,738 establishments is an average burden.
---------------------------------------------------------------------------

    \1\ Based on fiscal year 2015 data.
---------------------------------------------------------------------------

    In the Federal Register of September 8, 2016 (81 FR 62144), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                         Number of                    Average burden
       Activity/21 CFR section           Number of      records per    Total annual         per          Total
                                       recordkeepers   recordkeeper       records      recordkeeping     hours
----------------------------------------------------------------------------------------------------------------
Quality policy--820.20(a)...........          24,738               1          24,738               7     173,166
Organization--820.20(b).............          24,738               1          24,738               4      98,952
Management review--820.20(c)........          24,738               1          24,738               6     148,428
Quality planning--820.20(d).........          24,738               1          24,738              10     247,380
Quality system procedures--820.20(e)          24,738               1          24,738              10     247,380
Quality audit--820.22...............          24,738               1          24,738              33     816,354
Training--820.25(b).................          24,738               1          24,738              13     321,594
Design procedures--820.30(a)(1).....          24,738               1          24,738               2      49,476
Design and development planning--             24,738               1          24,738               6     148,428
 820.30(b)..........................
Design input--820.30(c).............          24,738               1          24,738               2      49,476
Design output--820.30(d)............          24,738               1          24,738               2      49,476
Design review--820.30(e)............          24,738               1          24,738              23     568,974
Design verification--820.30(f)......          24,738               1          24,738              37     915,306
Design validation--820.30(g)........          24,738               1          24,738              37     915,306
Design transfer--820.30(h)..........          24,738               1          24,738               3      74,214
Design changes--820.30(i)...........          24,738               1          24,738              17     420,546
Design history file--820.30(j)......          24,738               1          24,738               3      74,214
Document controls--820.40...........          24,738               1          24,738               9     222,642
Documentation approval and                    24,738               1          24,738               2      49,476
 distribution and document changes--
 820.40(a) and (b)..................
Purchasing controls--820.50(a)......          24,738               1          24,738              22     544,236
Purchasing data--820.50(b)..........          24,738               1          24,738               6     148,428
Identification--820.60..............          24,738               1          24,738               1      24,738
Traceability--820.65................          24,738               1          24,738               1      24,738
Production and process controls--             24,738               1          24,738               2      49,476
 820.70(a)..........................
Production and process changes and            24,738               1          24,738               2      49,476
 environmental control--820.70(b)
 and (c)............................
Personnel--820.70(d)................          24,738               1          24,738               3      74,214
Contamination control--820.70(e)....          24,738               1          24,738               2      49,476
Equipment maintenance schedule,               24,738               1          24,738               1      24,738
 inspection, and adjustment--
 820.70(g)(1)-(g)(3)................
Manufacturing material--820.70(h)...          24,738               1          24,738               2      49,476
Automated processes--820.70(i)......          24,738               1          24,738               8     197,904
Control of inspection, measuring,             24,738               1          24,738               5     123,690
 and test equipment--820.72(a)......
Calibration procedures, standards,            24,738               1          24,738               1      24,738
 and records--820.72(b)(1)-(b)(2)...
Process validation--820.75(a).......          24,738               1          24,738               3      74,214
Validated process parameters,                 24,738               1          24,738               1      24,738
 monitoring, control methods, and
 data--820.75(b)....................
Revalidation--820.75(c).............          24,738               1          24,738               1      24,738

[[Page 87575]]

 
Acceptance activities--820.80(a)-(e)          24,738               1          24,738               5     123,690
Acceptance status--820.86...........          24,738               1          24,738               1      24,738
Control of nonconforming product--            24,738               1          24,738               5     123,690
 820.90(a)..........................
Nonconforming product review/                 24,738               1          24,738               5     123,690
 disposition procedures and rework
 procedures--820.90(b)(1)-(b)(2)....
Procedures for corrective/preventive          24,738               1          24,738              12     296,856
 actions--820.100(a)(1)-(a)(7)......
Corrective/preventive activities--            24,738               1          24,738               1      24,738
 820.100(b).........................
Labeling procedures--820.120(b).....          24,738               1          24,738               1      24,738
Labeling documentation--820.120(d)..          24,738               1          24,738               1      24,738
Device packaging--820.130...........          24,738               1          24,738               1      24,738
Handling--820.140...................          24,738               1          24,738               6     148,428
Storage--820.150(a) and (b).........          24,738               1          24,738               6     148,428
Distribution procedures and records--         24,738               1          24,738               1      24,738
 820.160(a) and (b).................
Installation--820.170...............          24,738               1          24,738               2      49,476
Record retention period--820.180(b)           24,738               1          24,738               2      49,476
 and (c)............................
Device master record--820.181.......          24,738               1          24,738               1      24,738
Device history record--820.184......          24,738               1          24,738               1      24,738
Quality system record--820.186......          24,738               1          24,738               1      24,738
Complaint files--820.198(a), (c),             24,738               1          24,738               5     123,690
 and (g)............................
Servicing procedures and reports--            24,738               1          24,738               3      74,214
 820.200(a) and (d).................
Statistical techniques procedures             24,738               1          24,738               1      24,738
 and sampling plans--820.250........
                                     ---------------------------------------------------------------------------
    Total...........................  ..............  ..............  ..............  ..............   8,608,824
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29028 Filed 12-2-16; 8:45 am]
 BILLING CODE 4160-01-P