On November 8, the FDA issued final guidance on Medical Device Reporting for Manufacturers. 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.
This guidance supersedes the 2013 draft guidance and the 1997 manufacturer MDR guidance document.
The FDA will hold a webinar tomorrow to help manufacturers understand the information provided in this final guidance document. Following a brief presentation, the FDA will respond to participants’ questions. We welcome your questions about this final guidance, so please plan to join us. No registration is required.
Webinar Details: Date: November 30, 2016 Time: 1:00 pm - 2:30 pm EST
NOTE: You must dial-in to hear the presentation and ask questions: Dial: 888-456-0327, passcode: 8872340 International Callers Dial: 1-312-470-0074 passcode: 8872340
To view the slide presentation during the webinar: Participants can join the event directly at: https://www.mymeetings.com/nc/
join.php?i=PW1862037&p= 8872340&t=c Conference number: PW1862037 Audience passcode: 8872340
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
The slide presentation will be available the morning of the webinar at http://www.fda.gov/CDRHWebinar
. Following the webinar, a transcript and recording will be added to the site.
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.
U.S. Food and Drug Administration