On November 7th, 2016 the FDA issued final guidance on Medical Device Reporting for Manufacturers. This 53-page document is intended to assist medical device manufacturers striving to meet applicable reporting and record keeping requirements for 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and clarifies the agency’s interpretations of the regulatory requirements under 21 CFR part 803, superseding the 2013 draft guidance and the 1997 MDR guidance documents. You can download your free copy on the FDA website at: http://www.fda.gov/downloads/.
The FDA will be holding a webinar to help manufacturers understand the information provided in this final guidance document on Wednesday, November 30th, 2016 from 1:00 to 2:30 PM EST. Following a brief presentation, the FDA will respond to participants’ questions. No registration is required. To participate, dial: 888-456-0327 and enter passcode 8872340. International callers may dial: 1-312-470-0074 and also enter passcode 8872340.
To view the slide presentation during the webinar via your computer, 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 participation, it is recommended you join via computer 15 minutes prior to the scheduled start time for this event.
The slide presentation will be available the morning of the webinar at: http://www.fda.gov/CDRHWebinar . A transcript and recording will also be made available following the event.
Questions about the guidance document can be directed to CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, 1-800-638-2041 or 1-301-796-7100.
*IMPORTANT: Most of the information shared above was taken directly from an email very recently received from the U.S. Food & Drug Administration (FDA) containing a weekly digest of recent news. To subscribe, go to: https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_223
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