Understanding FDA Terms
In this episode of MedTech Crossroads, in2being Managing Director and host Gene Parunak highlights the true significance of some commonly misunderstood—and misused—Food and Drug Administration (FDA) terms:
The first term, registration, applies to companies that produce medical devices; the remaining terms all apply to products, the medical devices themselves.
First, the FDA requires all companies that manufacture or distribute medical devices to register with the FDA each year. So, if you see a company boasting in their marketing copy that they’re “FDA Registered,” all it means is that they’ve filed annual paperwork with the FDA.
Companies are also required to list all the medical devices they produce with the FDA. Every medical device on the market must be “FDA Listed,” so when you see this phrase in an advertisement, keep in mind that it only implies a minimal level of regulatory compliance.
Clearing, Granting, and Approval
The remaining three terms—clearance, granting, and approval—all concern regulatory pathways manufacturers can follow to obtain the right to market a new medical device legally. A device’s FDA classification usually determines its regulatory pathway. In general:
- Class I devices are subject only to the FDA’s general controls.
- Class II devices are subject to general and special controls and usually require clearance through the 510(k) process.
- Class III devices require more scrutiny than general and special controls—typically, clinical trials and approval through the FDA’s Premarket Approval (PMA) process.
Devices that demonstrate substantial equivalence to a legally marketed predicate device through a 510(k) submission receive FDA clearance.
Devices that are proven safe and effective through the PMA process are the only devices that can legitimately claim FDA approval.
An alternative is available if there isn’t a suitable predicate device for a new medical device and the device doesn’t require the level of scrutiny provided by the PMA process. You can bring the new device to market through an intermediate pathway known as a De Novo Request. If a De Novo Request is successful, it is granted.
So, the FDA uses the terms clearance, approval, and granting in very specific contexts. Disambiguating all five terms is useful for medical device developers and consumers. Don’t be fooled into thinking that “FDA Registered” or “FDA Listed” implies any approval or blessing from the FDA, and keep in mind that cleared, approved, and granted apply to particular regulatory pathways.
in2being is a full-service medical device consultancy that helps innovators bring new medical technology to market. To learn more about how we can help you with your new medical device, contact us today.