A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’. Intended Use and Indications for Use are key determiners and FDA provides clear guidance. Packaging and accessory definitions can be reasons for confusion. Follow the steps and resources below on determining product classification.

Determine if your Product is an FDA-defined ‘Medical Device’

1. 1. Check FDA Medical Device Definition vs. Your Intended Use, Information for Use <FDA link>
   2. Determine if a Product Classification exists for Your Product
      (FDA Product Class DB, Device PMA Approval/510(k) Clearance DB, Reg &Listing DB)
   3. Contact Division of Industry and Consumer Education (DICE)
   4. Email [email protected]
   5. Submit 513(g) – official FDA determination (fee)

Once you receive the official FDA classification, additional establishment registration and product listing steps are next. Compliance with FDA Unified Registration and Listing Systems (FURLS) is an annual activity for owners or operators of establishments that are involved in the production and distribution of medical devices in the US market.

FDA Establishment Registration & Product Listing

• Pay User Fee
  See Who Must Register, List and Pay the Fee
  See How to Register and List
  Pay annual Registration Fee at Device Facility User Fee (DFUF) website before registering Establishments and listing Products (2021 Fee = $5,672)
• Register Establishment (FURLS website)
   Establishments that are involved in the production and distribution of Medical Devices intended for commercial distribution in the U.S. are required to register annually with the FDA and pay an annual Registration Fee.
• List Product (FURLS website)
  Most establishments that are required to Register are also required to list the devices and the activities performed on those devices at their establishments.

See more in this 2:33 min Reed Tech Insight:

If you have questions about US FDA product data requirements for medical devices, get in touch with the experts at Reed Tech. [email protected] or call +1-215-557-3010