FDA Issues An Update To Working Model For Software Precertification
Published:
May 14, 2019
In January 2019, FDA issued an update to the Working Model for its Software as a Medical Device ("SaMD") Precertification Program. Readers are encouraged to read Finnegan's summary of the initial Working Model. Along with this version of the Working Model, FDA also issued two separate companion documents: the Regulatory Framework for conducting...
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