FDA Officials: Too Soon To Answer Device Industry Pre-Cert Questions

Officials from FDA’s device center say it is too early to answer many of industry’s questions about the agency’s nascent digital health software precertification program, including those asking what new authority FDA needs to implement the program. A medical device industry lawyer told Inside Health Policy he is especially concerned FDA will proceed with the program without legislative authority, instead relying on special controls as a “loophole." After building on the concepts of precertification and iterating on its working model...