The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review program (3P510K). Besides pointing out new updates to the program, it also details how the agency can use third party reviewers to evaluate emergency use authorization (EUA) requests, as mandated by Congress.
Under the 2020 3P510K guidance, FDA is allowed to recognize third-party reviewers who can review 510(k) premarket submissions to recommend an initial classification of certain low-to-moderate risk devices. The updated guidance also adds that the agency can contract with third-party reviewers to perform similar reviews of EUA devices. Such reviews, however, are not new, as FDA has worked with such organizations on third party reviewed EUAs (3PEUA) during the COVID-19 pandemic. FDA notes that the draft guidance is not in effect and will supersede the 2020 guidance when finalized…
