FDA Consulting Services extend our basic FDA U.S. Agent responsibilities with a comprehensive set of services to help a foreign manufacturer achieve a successful interaction with the FDA and with the export process.
FDA Consulting Services
- After selection we help the manufacturer through their initial registration.
- We help the facility renew their registration and update the registration for the annual renewal.
- We are responsible for making sure that the facility is informed of the renewal timeframes to that renewals can be completed on time.
- We help the facility classify and list their medical device according to the type of Device and intended use. We manage that listing and update the listing information as needed.
- We help the facility locate an Initial Importer, which is required for a foreign manufacturer to import devices into the United States.
- We help relay the requirements of the initial Importer to the manufacturer and help the manufacturer implement the any quality management system (QMS) that need to be in place at the manufacturer.
- We help the manufacturer prepare for an FDA audit by making sure the needed processes are in place early own
- We become the point of contact between the FDA and the company and quickly relay any information from the FDA to the company.
- We may help the manufacturer identify testing resources stateside, which could be cheaper and coordinate the delivery of samples for that purpose
- We locate 510(k) consultants to help the manufacturer submit their device for 510(k) clearance where needed.