Terms and Conditions:
1. 510k Express provides a 510k preparation service using information provided solely by the client. There are no other services offered or implied directly or indirectly other than the preparation of a 510k application.
2. 510k Express does not accept responsibility for the accuracy of the information provided by the client.
3. 510k Express does not provide US Agent or Regulatory Correspondent services of any kind as part of the 510k preparation service.
4. 510k Express is not responsible for the payment of any USFDA Fees. All such fees are payable solely by the client in the manner prescribed by the USFDA.
5. Successful receipt of a market access letter from the USFDA is NOT guaranteed, as this is a regulatory decision completely outside of 510k Express’ control.
6. Payment to 510k Express is by wire transfer only; any bank fees related to the transfer is the client’s responsibility. Payments are in US funds only.
7. There are no refunds.
Receiving an USFDA 510k approval will open medical device regulatory doors right around the world!
