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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.”
Rep. Henry Waxman (D-Calif.) has vowed to fight proposed legislation that would strengthen Project BioShield, saying the new proposal is a “misguided giveaway to the brand drug industry.”
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."