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 expects to normalize the performance of various types of organizational structures using the Excellence Principals. Also, while FDA will be responsible for all Excellence Appraisals during 2019, FDA is considering allowing FDA-accredited third parties to conduct the Appraisals in the future.

FDA listed the SaMD product-level elements that would be used to determine the risk category of the SaMD and therefore the and review pathway. For example, pre-certified organizations would have to provide information on the state of the healthcare condition, the core functionality of the SaMD product, a device description, and software performance characteristics. The Streamlined Premarket Review Process component was updated to include a proposed list of elements and their descriptions that would be reviewed, including product-specific elements such as the clinical algorithm, instructions for use, labeling review, software architecture, and validation. FDA considered how to streamline review for all submission types and presented a generic regulatory pathway that would be followed regardless of the submission type. FDA is still developing a Streamlined Review process that eliminates duplicative information, is interactive, and is automated where possible.

The Real-World Performance component was updated to include further descriptions of the three types of analysis expected in a real-world performance analysis plan: Real-world Health Analytics, User Experience Analytics and Product Performance Analytics. Examples were provided for each type of analysis that would allow for timely, feedback-orientated, and proactive measures. When the measures were taken appropriately, it would support maintenance of precertification for the manufacturer.

Readers are encouraged to read the Working Model, also available on FDA’s website. FDA is actively seeking public input to improve the Working Model and will be reviewing comments on the public docket as it refines the document.