December 08, 2016 by
EMERGO SUMMARY OF KEY POINTS:
- New legislation significantly impacting FDA oversight of US medical device and drug markets has passed Congress and is awaiting President Obama’s signature.
- The 21st Century Cures Act would establish a priority review program for breakthrough devices, loosen some device clinical trial requirements and clarify how and whether to regulate medical software.
- Critics of the new bill warn that efforts to streamline FDA regulations may end up allowing some devices into the US market without proper vetting, causing public health issues.
As legislation targeting a broad swath of US healthcare regulations awaits President Barack Obama’s signature after passage in the US Congress, effects of the pending law on registration and oversight of medical devices in the country will be significant.
The 21st Century Cures Act, which has garnered rare bipartisan support in Congress and is heavily backed by pharmaceutical and medical device industry lobbyists, would fast-track “breakthrough” and novel device registrations at the FDA, as well as alter clinical investigation requirements of manufacturers. Critics of the proposed legislation, however, warn of public health repercussions if FDA regulations of medical devices are made too lax.
Prioritizing “breakthrough” devices
Among the substantial changes to FDA medical device regulation included in the 21st Century Cures Act is a proposal to require the agency to set up a priority review program for “breakthrough” devices, or for devices targeting diseases for which no FDA-cleared or approved alternatives are available. The program would build upon a framework already in place at the agency for registration of such devices.
Under the program, a manufacturer or sponsor may request priority review designation before submitting its FDA registration application. The bill would authorize the Secretary of the US Department of Health and Human Services to develop and issue additional guidelines specifying parameters and requirements of the program.