Many startups proudly say, “We’re FDA registered!”
But what does this phrase really mean? Is it as much of a milestone as people think it is? Are there any drawbacks? Is it even a correct statement?
Let’s review the types of acknowledgements that the FDA has for devices and companies.
“Cleared” or “clearance” is reserved for devices that have submitted a successful 510(k) application. This acknowledgement covers most class II devices and some class I devices.
“Approved” or “approval” is reserved for devices that have received a successful PMA Class III Pre-Market Approval.
De Novo requests are “granted.”
FDA Registration and Listing
The focus of this article is on pre-market medical device companies. Every medical device company must register and list with the FDA within 30 days of beginning commercial activities in addition to complying with all applicable FDA regulations.
If your device is class I, there’s a good chance you don’t need “clearance” or “approval” from the FDA, but you will be subject to “registration” and “listing” when you put your device on the market. If your device is class II, you must have a cleared 510(k) or De Novo from the FDA before registration and listing occurs.
“Registration” actually refers to the company itself, not the product. FDA registers companies for specific products they sell, manufacture, sterilize, or reprocess. It’s the company that “registers” with FDA.
“Listing” refers to the devices (by name) that a company sells, manufactures, sterilizes, or reprocesses. A company can list or de-list specific devices once the company is registered.
Benefits and Drawbacks
Do registration and listing communicate any approval, clearance, blessing, good-will, thumbs up, or other good feelings from FDA?
In fact, registration and listing before the appropriate time comes with a couple of drawbacks for an early-stage startup:
The yearly registration fee is $4,884 (at the time of writing). This may represent a non-trivial expense to the small startup and must be renewed every year to maintain registration. Note that the FDA’s fiscal year starts in October, so if you register and pay in September, you will need to do so again in a month.
Registration subjects you to the possibility of an on-site FDA audit. This is an important service that the FDA provides to protect public health. Startups need to ask themselves, if their device isn’t actually ready for sale, are they ready to have the FDA show up at the door?
Anyone can register, and registration says nothing about the readiness of a device.
If you’re an investor, clarification of these terms should help cut through a few of the buzzwords that get thrown around. If you’re a startup, this should save you a few premature headaches.
If you have any questions about appropriate times for registration and listing, please don’t hesitate to reach out to discuss your particular situation.