Replacement heart valves and performance standards.
The international use of medical device standards is expanding for both economic and regulatory reasons. It is no longer adequate to have standards that only specify measurement methods and labeling for a product. An effort needs to be put forth between industry, academia and government to promote standards that also include a minimum set of acceptable performance criteria. This will allow for a less subjective evaluation of the conformance of the medical device to the appropriate standard as well as promote a uniform set of minimal performance expectations for a class of products among consumers.
Mueller
E P
EP
Department of Mechanics and Materials Sciences, U.S. Food and Drug Administration, Rockville, MD 20852, USA.
Regnault
W F
WF
D000818:Animals; D004869:Equipment Safety; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D011474:Prosthesis Design; D012015:Reference Standards; D014481:United States