On Monday, November 7, 2016, the FDA issued final guidance on Medical Device Reporting for Manufacturers. The FDA will hold a webinar on November 30, 2016 to help manufacturers understand the information provided in this final guidance document. Following a brief presentation, the FDA will also respond to participants’ questions.
Click here for more information on attending the FDA webinar.
The FDA intends that this guidance document assist medical device manufacturers in meeting applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. The FDA notes that 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 more than 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.
If you know of others who would like to be added to our email list to receive periodic updates on topics of interest in the medical device and pharmaceutical industry, please contact us. As always, Bowman and Brooke remains ready to help you address any of your legal needs.