- November 29, 2016
07:00 PM - 07:00 PM EST
On Monday November 7, 2016, 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.
The FDA held a webinar to help manufacturers understand the information provided in this final guidance document. Following a brief presentation, the FDA responded to participants’ questions.
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.
Food and Drug Administration
Center for Devices and Radiological Health