Source: https://www.federalregister.gov/articles/2007/07/09/E7-13152/agency-information-collection-activities-proposed-collection-comment-request-medical-devices-current
Timestamp: 2016-05-25 13:06:23
Document Index: 568146351

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

Federal Register | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
Publication Date: Monday, July 09, 2007
Dates: Submit written or electronic comments on the collection of information by September 7, 2007.
Comments Close: 09/07/2007
-37239 (5 pages)
Document Number: E7-13152
Shorter URL: https://federalregister.gov/a/E7-13152 Action
Submit electronic comments on the collection of information to: http://www.fda.gov/dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.
Medical Devices: Current Good Manufacturing Practice Quality System Regulations--21 CFR Part 820 (OMB Control Number 0910-0073)—Extension Back to Top
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 validating approved design changes before implementation of changes; and (10) the records and references constituting the DHF for each type of device.
The CGMP/QS regulation amends and revises the CGMP requirements for medical devices set out under part 820. The regulation adds design and purchasing controls; modifies previous critical device requirements; revises previous validation and other requirements; and harmonizes 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, nor 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, relabelers, and contract sterilizer firms, which are subject only to requirements applicable to their activities. In addition, remanufacturers of hospital single-use devices (SUDs) will now be considered to have the same requirements as manufacturers in regard to this regulation. The establishment, maintenance and/or documentation of procedures, records, and data required by this regulation will assist 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.
820.20(a)
820.20(b)
820.20(c)
820.20(d)
820.20(e)
820.30(a)(1)
820.30(b)
820.30(c)
820.30(d)
820.30(e)
820.30(f)
820.30(g)
820.30(h)
820.30(i)
820.30(j)
820.40(a) and (b)
820.50(a)(1) through (a)(3)
820.50(b)
820.70(a)(1) through (a)(5)
820.70(b) and (c)
820.70(d)
820.70(e)
820.70(g)(1) through (g)(3)
820.70(h)
820.72(a)
820.72(b)(1) and (b)(2)
820.75(a)
820.75(b)
820.75(c)
820.80(a) through (e)
820.90(a)
820.90(b)(1) and (b)(2)
820.100 (a)(1) through (a)(7)
820.100(b)
820.120(b)
820.120(d)
820.150(a) and (b)
820.160(a) and (b)
820.170(a) and (b)
820.180(b) and (c)
820.181(a) through (e)
820.184(a) through (f)
820.186
820.198(a) through (c)
820.200(a) and (d)
3,072,337
Potentially Affected Establishments: Except for manufacturers, not every type of firm is subject to every CGMP/QS requirement. For example, all are subject to FDA's quality policy regulations (§ 820.20(a)), document control regulations (§ 820.40), and other requirements, whereas only manufacturers and specification developers are subject to FDA's design controls regulations (§ 820.30). The type of firm subject to each requirement was identified by ERG.