Regulatory affairs and product integrity.
This review analyzes the regulations and control resulting from the Medical Device Amendments of 1976, and their effect on product integrity. There is a discussion on claims, safety considerations, recalls, cost factors, and the advantages and disadvantages of increasing governmental regulation of medical devices. A glossary of regulatory terms is included.
D003132:Commerce; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007878:Legislation as Topic; D014342:Truth Disclosure; D014481:United States