White House Reviewing FDA Guidance On 510(k) Third Party Review

The White House budget office is reviewing a final FDA guidance that allows 510(k) applications for low-to-moderate risk devices to be reviewed by a third party for review and only involve FDA for the final decision on the submission. FDA released the draft version of the guidance in September 2018 in response to an FDA Reauthorization Act mandate that the agency reduce the number of 510(k) submissions re-reviewed by the agency. The 2018 draft guide laid out how FDA would...