FDA to Host Software Precertification Pilot Program Interactive Session

The FDA plans to host a May 10 interactive session to discuss its progress on the Software Precertification Pilot Program.

The aim of the program is to help the agency to develop regulatory models to better analyze software’s safety and effectiveness without restricting patient access.

The program is currently limited to FDA-regulated Software as a Medical Device (SaMD), which the agency defines as software intended for use for at least one medical purpose that functions without being part of a hardware medical device.

In the upcoming session, the agency will discuss the program working model and seek feedback on potential next steps for the program.