Today FDA released its final guidance, “Medical Device Reporting for Manufacturers”. The goal of the document is to help manufacturers meet applicable reporting and recordkeeping requirements for specific adverse events and product malfunctions. The guidance supersedes the 2013 draft guidance, as well as the 1997 manufacturer MDR guidance document.
There have been numerous changes to the medical device reporting requirements since the FD&C Act first described them and the Medical Device Reporting regulation became effective over 20 years ago. The FDA’s final guidance on medical device reporting for manufacturers updates its policy and clarifies the agency’s interpretations of the regulatory requirements under 21 CFR part 803. – FDA release
FDA has also scheduled a webinar to help companies understand the final guidance and answer questions. The event takes place on Wednesday, November 30, 1–2:30 pm ET . The presentation slides will also be available the morning of the webinar.