Heart valve legislation and regulation.
During 13 years of regulation by the FDA under the Medical Device Amendments of 1976, the process by which replacement heart valves have been developed and modified has changed. Some of these changes have been good for the public, whereas other changes are of questionable value. Conditions will never be as they were 25 years ago, but they could be closer to what was expected in 1976. As the FDA constantly seeks to improve its performance and Congress focuses on possible changes to the Act, the cardiovascular community of practitioners, inventors, and manufacturers should offer their assistance. I believe the creative spirit that enables you as pioneers to reflect on your accomplishments and contemplate even greater innovations for the future should again be applied to the process of helping the FDA improve the way it serves us--the public.
McKenna, Conner & Cuneo, Washington, DC 20005.
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D006350:Heart Valve Prosthesis; D007883:Legislation, Medical; D014481:United States; D014486:United States Food and Drug Administration