FDA Wants Precertification Pilot Input

FDA says it is seeking public input and comment on an updated version of its software precertification program working model. An update notice (contains links to the updated working model, the comment docket, and other resources) says the new version outlines these pre-certification program key components: Excellence Appraisal and Determining Precertification Level, Review Pathway Determination, Streamlined Premarket Review Process, and Monitoring Real-world Performance.

“Stakeholders’ input on the software precertification pilot program working model will help inform the launch of the first version of the software precertification program by the end of 2018,” the notice says. “FDA continues to evaluate input we have received on the first version of the working model and future iterations of the working model will incorporate this input, as appropriate.”

The notice lists five new features in the working model.