Is there Unique Value in being FDA Registered?

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Many startups proudly say, “we’re FDA registered!”

But what does this valuable-sounding phrase really mean? And 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 FDA has for devices and companies:

“Cleared” or “clearance” is reserved for devices that have submitted a successful 510(k) application. This 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”.

If your device is class I, there’s a good chance you don’t need a “clearance” or “approval” from 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 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. So it’s the company that “registers” with FDA.

“Listing” refers to the devices (by name) that the company sells, manufactures, sterilizes, or reprocesses. A company can list or de-list specific devices once the company is registered.

Does registration and listing communicate any approval, clearance, blessing, good-will, thumbs up, or other good feelings from FDA?

No.

None.

Anyone can register, and the registration says nothing about the readiness of the device.

In fact, registration and listing before the appropriate time comes with a couple of drawbacks for an early-stage startup:

  1. The yearly registration fee is $4,884 (at the time of writing). This may represent a non-trivial expense to the small startup and has to be renewed every year to maintain registration. Note, the FDA’s fiscal year starts in October, so if you register and pay in September you will need to do it again in a month.

  2. Registration subjects you to the possibility of an on-site FDA audit. This is an important and good service that FDA provides to protect the 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?

If you’re an investor, this 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.

Please note: the focus of this article is on pre-market medical device companies. Every medical device company must register and list with FDA within 30 days of beginning commercial activities in addition to complying with all applicable FDA regulations.

Not Legal Advice

Gene Parunak