FDA (Food and Drug Administration) Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Irregular report

Technical Report · Tue Jan 01 04:00:00 EST 1991

OSTI ID:6148444

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: 6148444
• Report Number(s): PB-91-920900/XAB
• Country of Publication: United States
• Language: English

Related Subjects

61 RADIATION PROTECTION AND DOSIMETRY
655001* -- Medical Physics-- Radiation Protection Standards
APPLIANCES
COMPLIANCE
DOCUMENT TYPES
EDUCATION
INSPECTION
LASERS
MANUALS
MEDICAL SUPPLIES
MEDICINE
MICROWAVE OVENS
NATIONAL ORGANIZATIONS
NUCLEAR MEDICINE
OVENS
PLANNING
RADIOLOGY
STANDARDS
US FDA
US HEW
US ORGANIZATIONS