AHA objects to key parts of device regulations.
In the Nov. 26, 1991, issue of the Federal Register, the U.S. Food and Drug Administration (FDA) published its tentative final rule to implement the reporting requirements for the Safe Medical Devices Act (SMDA) of 1990. In the months before and after the rule's publication, the Chicago-based American Hospital Association studied the rule and offered guidance to its members and to the FDA on the act's reporting requirements. The rule's public-comment period ended March 27; here's a condensed version of what the AHA told the FDA.
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D000573:American Hospital Association; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D006268:Health Facilities / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration