The FDA has scrapped a proposal to review device applications under an informal, “pre-decisional” mechanism after feedback indicated that such a process would be inefficient rather than facilitating an investigational device exemption application, according to a guidance document on IDE decisions published Aug. 18.
An approved IDE allows the initiation of subject enrollment in a clinical investigation of a significant risk device, the Food and Drug Administration said in the guidance.
“FDA seeks to encourage medical device research and innovation to address important clinical needs and improve patient care. In many cases, device development and evaluation include clinical investigation. This ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.