Tag Archives: MDR

FDA Finalizes Voluntary Malfunction Summary Reporting Program to Streamline Manufacturer Reporting

On August 17, 2018, FDA announced that it finalized its Voluntary Malfunction Summary Reporting Program (“Program”).  The Program is intended to reflect the goals for streamlining manufacturer malfunction reporting that FDA and industry agreed to in the Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter.  The finalized Program is based on positive findings … Continue Reading

FDA Issues Draft Guidance on Medical Device Reporting for Manufacturers

On July 9, 2013, FDA announced the availability of a draft guidance document titled “Medical Device Reporting for Manufacturers.”  Written in a question and answer format, the draft guidance provides FDA’s current views on FDA’s Medical Device Reporting (MDR) regulation, 21 C.F.R. part 803.  Once finalized, the draft guidance will supersede the agency’s previous 1997 … Continue Reading