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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:52602­
52662, October 7, 1996.

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

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

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

5. "Guidance on Quality Systems for the Design and Manufacture of Medical
Devices," 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 for
Quality Plans," ISO/DIS 9004-5, Geneva, ISO, 1994.

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

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

GENERAL PROVISIONS

QUALITY SYSTEM REQUIREMENTS

DESIGN CONTROLS

REFERENCES

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