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ERIC Number: ED314928
Record Type: RIE
Publication Date: 1987-Aug
Pages: 35
Abstractor: N/A
Reference Count: N/A
ISBN: N/A
ISSN: N/A
Regulatory Requirements for Devices for the Handicapped.
Stigi, John, Ed.; Rivera, Richard J., Ed.
This booklet explains in question/answer form the basic regulatory requirements established by the Food and Drug Administration (FDA) of the federal government concerning the manufacture, marketing and distribution of medical devices (including implantable devices and devices previously regulated as drugs) for persons with disabilities. Topics covered include: the definition of a handicapped person, classification of medical devices (according to the amont of control needed to assure the device's safety and effectiveness), implantable devices, devices previously regulated as drugs (transitional devices), registration and listing, premarket notification, good manufacturing practices, performance standards, premarket approval, investigational device exemptions, custom devices, trade secrets and confidential information, and color additives for devices. (PB)
Publication Type: Legal/Legislative/Regulatory Materials
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: Food and Drug Administration (DHHS), Rockville, MD. Center for Devices and Radiological Health.