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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Digital Health Roundup: Digital Therapeutics Push Ahead On Standards, Coverage; FDA’s Software Guidance
In this roundup feature focusing on developments in digital health, we highlight the key news and announcements from October.
A US FDA regulatory expert offers insight into what companies can expect from the agency as it braces to transition potentially hundreds of emergency use authorized (EUA) products to full marketing authorization.
The principals recommended by the three countries could be the foundation for how their regulatory bodies intend to regulate future AI/ML products.