With the smell of pumpkin spice lattes in the air and the taste of warm apple cider doughnuts, comes another special time of year: FDA’s device registration renewal period!
Beginning October 1 – December 31, 2023, all foreign and domestic medical device establishments must register and renew their device establishment registration with FDA. This applies to owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. The registered establishment is also required to list the devices that are made at the establishment and the activities performed on those devices.
Medical device registration helps provide FDA with the location of medical device establishments and the devices manufactured at those establishments. It provides tracking and tracing of medical device facilities, both foreign and domestic, to increase FDA’s ability to respond to public health emergencies more quickly and efficiently.
The regulations require that a medical device establishment renew its registration and listing during the period beginning on October 1 and ending on December 31 of each year. Failure to renew a medical device establishment registration is considered a prohibited act and may result in enforcement actions, including injunction or prosecution. Specifically, FDA regulations provide that the failure of an establishment to register with the FDA causes the devices manufactured or processed in such an establishment to be misbranded and therefore subject to refusal of admission. Accordingly, medical device establishment registration is a threshold requirement for U.S. compliance of medical devices. Â
FDA announced that its FY 2024 (October 1, 2023 – September 30, 2024) fee is $7,653. While there are small business exemptions for marketing applications, there are unfortunately no exemptions from the registration fees. Businesses are required to submit all registration and listing information electronically unless the Company has received a waiver.
As a reminder, the medical device facility registration and listing requirement applies to owners and operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. This includes:
- Manufacturers/remanufacturers
- Kit Assemblers
- Repackagers/relabelers
- Contract Manufacturers/Sterilizers
- Specification Developers
- Reprocessors of Single Use Devices
- Complaint Handlers
- Foreign Exporters and Private Label Distributors
- Initial Imports (Initial Distributors)
There are a number of operations and facilities that may be exempt from U.S. medical device establishment registration. It is important to have in-house regulatory affairs and/or outside regulatory counsel examine your facility’s operations to determine if your establishment is exempt. We also recommend that you keep a regulatory rationale on file for support.
Generally, the following types of establishments are not required to register.
- Component manufacturers who provide raw materials and/or components used in the manufacture or assembly of a device
- Manufacturers of devices used solely for veterinary purposes
- Retail establishments that provide medical devices directly to end users
- Licensed practitioners, including physicians, dentists and optometrists, who manufacture or otherwise alter devices solely for use in their practice
- Manufacturers whose devices are strictly used in research, teaching or analysis and not introduced into commercial distribution.
We recommend device companies renew existing registrations in the next few weeks, and not wait until end of year. Additionally, if you are a first-time device registrant, now is a good time to initiate your device registration.
If you would like Garg Law to assist you with device registration (initial registration or renewal), please visit Device Registration and learn more here.
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For further questions on device establishment registration and listing, and U.S. agent services, please contact us at info@garg-law.com.
