Should a company register and list with the FDA?

Engineering & Quality Solutions, Inc. often gets asked about FDA registration and listing…Which companies needs to register and list devices? When should a new or start-up device company register? Should a contract manufacturer be registered? The rules have changed over the years and the answer depends on the company, its products & services, and other factors. The link below to the FDA website provides guidelines on this sometimes complex subject. If you’re wondering about FDA registration and device listing for your company, feel free to contact us and we can help you determine the best path.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm#contractmanufacturer