The US Food and Drug Administration’s device center has published its A and B lists of guidance documents it plans to prioritize in fiscal year 2023. Posted annually, the lists are broken down into two tiers, with the A-list containing the guidances the agency intends to give top priority to in FY2023 and the B-list reserved for those the agency will get to if resources and time allow.
Guidance On Regulating AI As A Medical Device Not Top 2023 Priority For FDA
Industry Attorney Offers His Perspective On Why It Should Be
The US FDA’s Center for Devices and Radiological Health has posted the guidance documents it plans to focus on in fiscal year 2023, and guidance on regulating AI as a medical device is not first up.
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