Source: https://www.federalregister.gov/documents/2013/12/10/2013-29394/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2017-08-20 01:04:49
Document Index: 513755032

Matched Legal Cases: ['art 820', 'art 820', 'art 606', '§\u2009820', '§\u2009820', '§\u2009820', '§\u2009820', '§\u2009820', 'art 820']

Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices Current Good Manufacturing Practice Quality System Regulation
78 FR 74146
74146-74151 (6 pages)
2013-29394
FDA-2013-N-0853
https://www.federalregister.gov/d/2013-29394 https://www.federalregister.gov/d/2013-29394
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 Start Printed Page 74147and 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.
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 Start Printed Page 74148records, 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.
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 § 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 (SUDs) are now to be 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 25,986 respondents. A query of the Agency's registration and listing database shows that approximately 15,113 domestic and 10,873 foreign establishments are respondents to this information collection.[1] These recordkeepers consist of manufacturers, subject to all requirements and contract manufacturers, specification developers, re-packers, re-labelers, and contract sterilizers, subject only to requirements applicable to their activities. Hospital remanufacturers of SUDs are now defined to be manufacturers under guidance issued by FDA's Center for Devices and Radiological Health, Office of Surveillance and Biometrics. 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 PRA burden placed on the 25,986 establishments is an average burden.
Another part of the comment expressed a belief that “the burden on industry of complying with FDA requests for information during an inspection is based on data FDA maintains on actual inspections; the estimates are averages” and that “it is unclear how FDA arrived at these estimates since they seem high when spread out across all registered device manufacturers.”
The comment assumes that the burden estimate includes only the burden of responding to information requests during an inspection. However, Start Printed Page 74149the estimates also include the burden of collecting, maintaining, and retaining the records. The comment's suggestion of 3.5 hours per year for “responding to information requests during an inspection” does not appear to include the burden of collecting, maintaining, and retaining the records and is based on the experience of only one segment of industry. 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 estimated burden is, therefore, an average burden.
The comment also suggests that FDA did not make clear what was meant by the “quality, utility, and clarity of the collected information” in the 60-day notice requesting public comment on the information collection. “Quality, utility, and clarity” have the same meaning as in OMB's regulations at 5 CFR 1320.8(d)(1)(iii).
Another part of the comment addressed concerns about the use of electronic means to fulfill the information collection requirements. The comment seems to assume that it would take additional time to provide electronic records at the request of an inspector because records that are not kept in electronic format would need to be scanned in order to fulfill the inspector's request. The comment also requests that FDA “publish procedures for the use of any electronic submissions which may be contemplated” to help the commenter allay concerns about misuse of photographs and electronic submissions.
At this time, fulfillment of the information collection via electronic means is optional. We estimate that approximately 75 percent of respondents currently use some form of electronic recordkeeping to fulfill the information collection. Firms may use appropriate technology in accordance with FDA's “Electronic Records; Electronic Signatures” final rule (62 FR 13430; March 20, 1997) to comply with the CGMP/QS recordkeeping requirements. However, respondents may make the records available in paper format. There is no additional requirement that respondents convert existing paper records to an electronic format.
The comment also requests an explanation regarding the citation of the standard “ISO 9001” in the 60-day notice for public comment, rather than “ISO 13485.”
In the notice, we included background information regarding the Quality System Regulation (part 820). We referenced “ISO 9001: Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing” because at the time the Quality System Regulation was issued and the preamble was written, ISO 9001 was the current standard.
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[FR Doc. 2013-29394 Filed 12-9-13; 8:45 am]