This morning I was welcomed by receiving an email from the FDA CDRH News stating that new guidance was released regarding user fees and refunds for pre-market notification submissions 510(k)s. Some of the takeaways I had were:
1. When a user fee is applicable
2. Fees associated with "Not Substantially Equivalent" determination
3. Fees associated with 3rd Party reviewed 510(k)s
4. Fees for additional 510(k) information provided
5. Fees for resubmitted 510(k)s
My focus was predominantly on understanding the scenarios for submitting 510(k)s to the FDA and what the submission costs would be. The FDA guidance also provided valuable information related to when refunds of fees are applicable. Feel free to visit the full guidance document at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm345277.htm?source=govdelivery . This link provides access to additional resources for educating yourself on better understanding 510(k) submissions.
- MJB