In January 2019, in conjunction with Version 1.0 of its Working
Model for the Software Precertification Program, FDA issued a 2019
Test Plan for testing the software
precertification model before employing it as a full-scale
alternative premarket pathway for software as a medical device
(“SaMD”) products. The primary purpose of the Test Plan
is to assess whether the Excellence Appraisal process and
Streamlined Review components of the precertification program, as
described in the Working Model, together produce an equivalent
basis for determining reasonable assurance of safety and
effectiveness for SaMD products.
The Test Plan will consist of retrospective and prospective
testing on a series of test cases. For retrospective testing, FDA
will extract elements that are proposed to be included in a
Streamlined Review from a previously-reviewed, complete submission
package for a SaMD product. FDA will review this set of
product-specific data then determine what
