FDA Moves Closer to Requiring All Submissions for 510(k) Devices To Be Provided in Electronic Format
September 29, 2021 at 04:18 PM EST
The FDA has taken the next step toward requiring all premarket notification (510(k)) submissions to the agency for medical devices to be provided electronically. The requirement may be in effect by September 2023.
A Sept. 29 draft guidance from the FDA — the first to specify the format for electronic device submissions and a possible timeline for implementing an electronic su... Read More
