FDA Makes Quality the Rule (continued)FDA Makes Quality the Rule (continued)

An MD&DI January 1997 Feature Article

1. "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule;Quality System Regulation," Federal Register, 61 FR:52602­52662, October 7, 1996.

2. Code of Federal Regulations, 21 CFR 820, "Good Manufacturing Practicefor Medical Devices," 43 FR:31508, July 21, 1978.

3. "Medical Devices; Current Good Manufacturing Practice (CGMP)Regulations; Proposed Revisions; Request for Comments," 58 FR:61952­61986, November 23, 1993.

4. "Medical Devices; Working Draft of the Current Good ManufacturingPractice (CGMP) Final Rule; Notice of Availability; Request for Comments; PublicMeeting," 60 FR:37856, July 24, 1995.

5. "Guidance on Quality Systems for the Design and Manufacture of MedicalDevices," issue 7, Global Harmonization Task Force, August 1994.

6. "Quality Systems--Model for Quality Assurance in Design, Development,Production, Installation, and Servicing," ISO 9001:1994, Geneva,International Organization for Standardization (ISO), 1994.

7. "Quality Management and Quality System Elements, Part 5: Guidelines forQuality Plans," ISO/DIS 9004-5, Geneva, ISO, 1994.

8. "Quality Systems--Medical Devices--Particular Requirements for theApplication of EN 29001," European Norm 46001, Brussels, European Committeefor Standardization, 1996.

9.Design Control, MD&DI Reprint Series, Santa Monica, CA, CanonCommunications, 1994.

GENERAL PROVISIONS

QUALITY SYSTEM REQUIREMENTS

DESIGN CONTROLS

REFERENCES