FDA (Food and Drug Administration) Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Basic section
The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.
- Research Organization:
- Food and Drug Administration, Rockville, MD (USA)
- OSTI ID:
- 6349787
- Report Number(s):
- PB-89-920999/XAB; FDA/OMO-89/6D
- Resource Relation:
- Other Information: Supersedes PB--88-920999. Portions of this document are not fully legible; Updates and basic manual available on subscription as PB--89-920900
- Country of Publication:
- United States
- Language:
- English
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FDA (Food and Drug Administration) Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Irregular report
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