FDA Corrects Electronic Medical Device Reporting Rule To Re-Include UDIs

FDA has taken steps to fix a mistake in a final rule approved in February 2014 that required device manufacturers to submit device reports electronically but inadvertently excluded unique device identifiers from reporting requirements. The agency realized its mistake and fixed it, according to a Federal Register notice released Friday (Feb. 27). The UDI rule, finalized in September 2013, required UDIs to be in medical device reporting reports (MDR). An industry consultant said he believes FDA wrote the initial eMDR...