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Home » MDR Rule Undergoes Changes for Language Clarification
MDR Rule Undergoes Changes for Language Clarification
April 7, 2005
More than six years after the issuance of a presidential memorandum designed to ensure regulations are stated in plain language, the FDA is proposing to amend its regulation governing reporting of deaths, serious injuries and certain malfunctions related to medical devices in order “to make the regulation easier to understand.”