CDS Coalition Provides Feedback on Version 0.2 of FDA’s Software Precertification Program Working Model
The Coalition compliments FDA on both its vision for a better, more effective regulatory approach for software as a medical device (“SaMD”), as well as the Agency’s approach of periodically putting drafts of the working model out for public comment. Further, and as stated in our prior comments, the Coalition believes this is an incredibly important initiative that the Agency is undertaking. However, we offer comments on five different topics:
- How does the precertification program address low risk and ultra-low risk products?
- The need to include software used with drugs.
- Missing programmatic elements.
- What is FDA’s claimed legal authority for conducting the pilot program in 2019 and for implementing the program thereafter?
- The staffing challenges of regulating corporate entities and their cultures, as compared to evaluating the safety and effectiveness of a device.