September 17, 2020

FDA Update on the Digital Health Software Precertification Program

On September 14, FDA issued an  update on the status of the Digital Health Software Precertification (“Pre-Cert”) Pilot Program, including a summary of learnings and ongoing activities. Launched in 2019, Pre-Cert allows for more streamlined regulatory oversight for Software as a Medical Device (SaMD) manufacturers who demonstrate safety and effectiveness in product development and during the product lifecycle. Within the update, FDA notes that the public health emergency has highlighted the utility of flexible, tailored regulatory approaches and identifies how Pre-Cert will move to its next iteration of building and testing.