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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.

Two lane road

The US Food and Drug Administration’s device center on 26 October published its annual list of guidance documents it will prioritize in fiscal 2022, including drafting guidances to help manufacturers transition COVID-19 emergency products to full marketing status and focus on digital health technologies.

As it does yearly, the FDA broke down its list of priority guidances by two tiers, A and B....

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