Appeal-Not-Substantially Equivalent (NSE) final decision
Compliance Consultants has overturned final determinations of 510(k)s by the FDA and reversed decisions in favor of clients. We have appealed and won Final decisions of NSE submissions. Our first appeal was before FDA/CDRH/ODE had a specified appeal process. Since ODE had no procedure to re-instate a rejected 510(k). We insisted that the process favor our client. Our argument prevailed. The 510(k) was approved. We worked with ODE to implement a “re-instatement” process. ODE later defined an appeal process based on our pioneer efforts in behalf of this client.Our last appeal was in the summer of 2014 with the new director of the ODE.
Compliance Consultants can appeal NSE decisions for other consultants and sponsors (for applications we did not create). There is a time limit after which no argument will be heard.
