Transparency in the jurisdictional decision making process is a goal of FDA. Accordingly, FDA is providing redacted RFD decision letters and capsular descriptions of jurisdictional determinations for products that have been approved (refer to web pages listed below). Such transparency in jurisdictional decision making should result in greater predictability and consistency of decisions, and decrease ambiguity and uncertainty about FDA perspectives. Moreover, as the bases for FDA decision making become clearer, the need for formal RFD’s and informal inquiries covering specific products may be diminished, which should conserve resources for both industry and FDA.
Capsular Descriptions of Jurisdictional Determinations
- Capsular Decisions - Products Assigned to CBER
- Capsular Decisions - Products Assigned to CDER
- Capsular Decisions - Products Assigned to CDRH
Redacted Decision Letters