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See today's BioWorld MedTech
Home » FDA’s software pre-cert program to advance only incrementally
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2022 MedCon

FDA’s software pre-cert program to advance only incrementally

May 5, 2022
By Mark McCarty
The U.S. FDA’s pre-certification (pre-cert) program for software as a medical device (SaMD) seemed to run out of steam before the COVID-19 pandemic arrived, but the FDA was always presumed to need help from Congress to roll out a permanent version. A session at this year’s MedCon suggests that there is still life left in the pilot version of the SaMD pre-cert program, a critical development given that the legislation for the device user fee program offers the FDA no new statutory authority for a novel software regulatory framework.
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