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.