Refuse to Accept
The Refuse to Accept process is a new layer of scrutiny imposed by the FDA/CDRH/Office of Device Evaluation. It is a multiple page document used when a new 510(k) is submitted. The submission is judged for presences or absences of many elements.Many of the elements have been added as part of the implementation of this form and were not required before. Many elements are not required according to existing guidance documents but are now mandated in this new process as an absolute.
If an element is absence, then FDA is supposed to accept a rationale from the submitter as to why the element has been omitted. The problem is FDA ignores the rationale and “returns your submission”.
Compliance Consultants has been successful in resolving absence elements in the sponsor’s behalf.
