In January 2019, in conjunction with its Version 1.0 of the Working Model for the Software Precertification Program, FDA issued a regulatory framework for conducting a precertification pilot program, which it has currently limited to software as a medical device (SaMD). SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. Specifically, FDA plans to initially implement the precertification pilot program under its current De Novo pathway. FDA’s De Novo pathway is a process for certain new types of low to moderate risk medical devices to obtain marketing authorization as a class I or class II device, rather than remaining automatically designated as a class III device, which would typically require FDA premarket approval.

Participants in the pilot who have a software a as medical device (“SaMD”) product eligible for De Novo classification could also participate in an Excellence Appraisal conducted by FDA, as outlined in the Working Model. An excellence-appraised manufacturer would then submit a De Novo Request containing the required submission content. This “Pre-Cert De Novo Request” would be streamlined and include the relevant submissions of a traditional De Novo that, in addition to the elements documented during the Excellence Appraisal, provide the information to determine that the product is of low to moderate risk and that controls can provide a reasonable assurance of safety and effectiveness. After review, FDA would classify the device by a written De Novo order.

The De Novo order would establish a classification that enables 510(k) submissions to market a device of the same type, in form of a “Pre-Cert 510(k).” FDA expects that review of a Pre-Cert 510(k) would be more efficient than the review of a traditional 510(k). After the classification through the De Novo order, modifications to a device would be assessed in accordance with the relevant FDA’s guidance on submitting a 510(k) for a software change to an existing device to decide whether the modification could significantly affect safety and effectiveness or is a change to the intended use of the software.