FDA Posts Webinar Describing New Medical Device Reporting Requirements

Last month, we reported that New Guidance on Medical Device Reporting Supersedes Guidance in Use Since 1997. This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. 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. Click here for a webinar, printable slides or transcript of the webinar or feel free to contact us if you need help with medical device-vigilance, to include QSR SOP development and QSR compliance, or drug safety surveillance to include PADERs, ISS and/or labeling updates