Medical Industry Updates
Highlights of Medical Device Related Provision in the 21st Century Cures Act:
Congress has just passed, and the President has indicated he will sign, the 21st Century Cures Act (Cures Act) (H.R. 34). The Cures Act has a host of provisions intended to improve how the FDA reviews and approves drugs and medical devices.
This program will no doubt build on FDA’s already-established Expedited Access Pathway (EAP). Unlike the EAP program, the legislation opens priority review to device types subject to 510(k) clearance and not just PMA approval or de novo requests.
A quick summary of the device related provisions can be found here.
FDA Final Guidance on Medical Device Reporting for Manufacturers
On November 30, 2016, FDA held a webinar regarding the November 7, 2016 FDA issuance of the final guidance on Medical Device Reporting for Manufacturers. This guidance document is intended to assist medical device manufacturers meet applicable reporting and record keeping 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 presentation, printable slides and transcript can be viewed here.
