FDA Issues An Update To Working Model For Software Precertification

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 the pilot program within current authorities and the Test Plan that describes how FDA intends to assess whether the programs are providing an equivalent basis for determining reasonable assurance of safety and effectiveness for SaMD products.

The update describes that the previous components of the Working Model—excellence appraisal, review pathway determination, streamlined review, and real world performance—are part of a Total Product Lifecycle approach that allows for continued monitoring and evaluation of a product's safety throughout its lifecycle.  The Excellence Appraisal component was updated to reflect that FDA