In my opinion, registration and listing is the simplest and most intuitive regulation for medical devices. It’s a quick and fairly painless online process if you read and follow FDAs detailed instructions. Device Registration and Listing | FDA
The FDA is simply trying to keep track of the medical devices that are produced or imported into the U.S. Knowing who is making what is an obvious precursor step to monitor manufacturers, identify potential problems, and contact them as needed.
Registration & Listing
If you can remember the following three rules, you will be in good shape.
Rule 1: ‘Establishments’ must register and list their devices unless they get a waiver.
Don’t get your hopes up– you probably don’t qualify for a waiver.
Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed
But please note that ‘establishments’ include a far wider scope than you might guess, including locations that design and develop products, repackage or relabel, or sterilize: Full list of activities here: Domestic Establishments | FDA
Rule 2: Establishments must review and update registration and listings annually
You will be required to pay a fee up front for this privilege.
Rule 3: Establishments must update their registration and listing information within 30 days of certain changes
This includes changes to…
- name, address, or ownership of the establishment.
- devices with activities at the establishment
- activities that are performed(e.g. design, manufacturing, repackaging, etc.).
- status of the devices (commercially distributed, discontinued, or resumed)
- premarket submission number (510 (k), De Novo, PMA, PDP, HDE) for the devices
- importers and persons who import or offer for import the devices
NOTE: This blog covers only 21 CFR Part 807 subparts A to D. Part E covers premarket notifications (a type of submission) and will be described in a later blog.
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