FDA unveils draft guidance for quick feedback on devices

In keeping with its pledge to work with devicemakers to speed up the approval process, the FDA has released draft guidance on a prospective pre-submissions program, allowing companies to get early feedback before submitting devices for approval.

The proposed program would allow devicemakers to file a pre-sub before conducting clinical studies or before applying for approval, and the FDA hopes the program will reduce the regulatory hurdles companies face by looping in the agency before starting the PMA process. Furthermore, the FDA is offering to hold informal meetings with devicemakers before starting approval hearings.

Of course, the pre-sub program is not an alternative to traditional approval and clearance processes, the FDA warns. Instead, the program is designed for first-in-kind and novel devices that may normally face a protracted PMA process, allowing the agency to lend its advice on how to conduct clinical trials and develop applications before devicemakers get started on the path to approval.

The draft guidance is a good-faith effort on the FDA's promise to work with the industry to make the device investigation process quicker and more predictable. The latest user fee bill, signed by the president this week, more than doubles the charge devicemakers pay the agency, but comes with the stipulation that the FDA will reform its ways.

- read the draft guidance
- here's Regulatory Focus' take
- get more from MedCity News

Suggested Articles

Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies.

Cellex has announced plans to develop a rapid coronavirus test that people can fully perform at home, from sample collection to result, using an app.

More than 20 states either don’t release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus.