Message from “Ray:” How can companies run ads for non-cleared or approved devices that say “FDA registered?”
Thank you, Ray, This issue comes up from time to time, and we addressed it in a March 13, 2015 post. FDA registration does not necessarily imply that a device is approved or cleared, as defined in this statement from the FDA web site: Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.
Congress has authorized FDA to collect an annual establishment registration fee for device establishments. A detailed list of the types of device establishments that are required to register and pay the fee can be found at “Who Must Register, List and Pay the Fee”. There are no reductions in annual establishment registration fees for small businesses or any other group.
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.