FDA announced the next phase of its Pre-Cert Test Plan implementation. Pre-Cert refers to the the pre-certification program that FDA’s Digital Health unit has been piloting. The program targets SaMD devices only at this time.
This next phase seeks SaMD companies, willing to volunteer, that foresee a De Novo request or 510(k) submission within the next year. In January of 2019, FDA shared a high level view of the Test Plan which outlines a framework for safety and efficacy of SaMD products through pre-appraisal of processes and methodologies for software validation. This next phase is the latest iteration by FDA in developing the Pre-Cert framework.