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

Published date15 November 2019
Record Number2019-24805
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 84 Issue 221 (Friday, November 15, 2019)
[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
                [Notices]
                [Pages 62534-62537]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-24805]
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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 Devices;
                Current Good Manufacturing Practice Quality System Regulation
                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 (PRA).
                DATES: Fax written comments on the collection of information by
                December 16, 2019.
                ADDRESSES: To ensure that comments on the information collection are
                received, OMB recommends that written comments be faxed to the Office
                of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
                Fax: 202-395-7285, or emailed to [email protected]. All
                comments should be identified with the OMB control number 0910-0073.
                Also include the FDA docket number found in brackets in the heading of
                this document.
                FOR FURTHER INFORMATION CONTACT: 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: In compliance with 44 U.S.C. 3507, FDA has
                submitted the following proposed collection of information to OMB for
                review and clearance.
                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 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.
                [[Page 62535]]
                 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 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
                [[Page 62536]]
                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 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.
                 In the Federal Register of July 31, 2019 (84 FR 37317), 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 hours
                 recordkeepers recordkeeper records recordkeeping
                ----------------------------------------------------------------------------------------------------------------
                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)......................
                [[Page 62537]]
                
                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-820.70(h) 27,074 1 27,074 2 54,148
                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
                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 product- 27,074 1 27,074 5 135,370
                 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 activities- 27,074 1 27,074 1 27,074
                 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 reports- 27,074 1 27,074 3 81,222
                 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: November 6, 2019.
                Lowell J. Schiller,
                Principal Associate Commissioner for Policy.
                [FR Doc. 2019-24805 Filed 11-14-19; 8:45 am]
                 BILLING CODE 4164-01-P
                

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