Hamburg, 13.03.2019, Andreas Genßler
FDA – new RTA (Refuse to Accept) Policy for 510(k)s and RTA Checklist published February 21, 2019
FDA has recently published a new RTA checklist for the submission of premarket notifications 510(k).
The two major changes are the addition of:
- Statements of Compliance for Clinical Investigations for investigations conducted inside and outside of the United States
- Declaration of utilized voluntary consensus standard(s)
Apart from the major changes a few minor clarifications with regards to terms and positions were made.