FDA Guidance Priorities For FY 2022 Include Transitioning EUAs; List Includes CDS Software Again
The US agency’s device center on 26 October published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including drafting guidances to transition emergency use authorized products to full marketing status, and finalizing a clinical decision support software guidance that’s been four years in the making.
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FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program
The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
FDA Puts Finishing Touches On Draft Guidance To Set Case For Quality VIP Program In Stone
The goal of the guidance is to make the Case for Quality Voluntary Improvement Program, or CfQ VIP, “more official” at the US FDA, an agency official says. CfQ VIP aims to elevate product, manufacturing and process quality at medical device firms.
EUA Draft Guidance: FDA Wants ‘Transition Implementation Plan’ Along With Marketing Submission
In a long-awaited draft guidance document, the US agency lays bare its thinking on how companies can best ensure that their products granted emergency use authorization status can still be sold post-pandemic (or not).