Cleared, approved, registered: what FDA means

"FDA cleared" means a 510(k) clearance

FDA describes a premarket notification, known as a 510(k), this way:

“A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device”

“Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution”

The comparison device is called the predicate:

“The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."”

FDA's page sets out who must submit one:

“Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)”

and, for changes to a device that's already on the market:

“A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different intended use.”

What that means for reading a record: a clearance is a decision about the device described in the company's submission, for the use in its indications statement. A clearance for one model or use doesn't by itself establish clearance for another. FDA also notes:

“Please note that FDA does not typically perform 510(k) pre-clearance facility inspections.”

612 of the records on this site are 510(k) clearances.

"De Novo granted" is a different route

“The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.”

“Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, when applicable.”

In other words, De Novo classifies a new type of device into Class I or Class II when there is no legally marketed predicate. A De Novo grant isn't a substantial-equivalence decision. 2 records here are De Novo grants, labelled "De Novo granted", not "cleared"; their numbers start with DEN and they are listed in FDA's De Novo database.

"FDA approved" for devices: PMA and HDE

Premarket approval (PMA) is one device approval pathway:

“Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.”

“PMA is the most stringent type of device marketing application required by FDA.”

Another is the humanitarian device exemption:

“Humanitarian Device Exemption (HDE): a marketing application for an HUD”

FDA's page refers to selling a device “after receiving an HDE approval” (FDA: Humanitarian Device Exemption). FDA's consumer guide sums up the split for most devices:

“The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing.”

“may market such devices pursuant to so-called “510(k) clearance,” allowing distribution once the manufacturer has demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.”

Every product code this site covers is Class II, and none of its records is an approval. A product described as "FDA approved" still needs a record that names it before its status can be checked.

"FDA registered" and "FDA-registered facility"

Establishment registration and device listing are separate requirements. FDA says:

“Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.”

“Generally, device 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.”

“Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments.”

Which requirements apply depends on what an establishment does. Neither is a review of the product:

“Mere registration of an establishment or listing of a drug or device does not denote approval of the establishment, the drug or device, or other drugs or devices of the establishment, nor does it mean that a product may be legally marketed.”

“the agency does not approve manufacturing facilities independently.”

"Made in an FDA-registered facility" on a box is the seller's claim. Even when the claim is accurate, it says nothing about whether that device was cleared.

Gels, serums and creams sold with a device

A device record describes the device. It doesn't tell you the regulatory status of a gel, serum or cream sold with it. For products that are cosmetics, FDA says:

“Cosmetic products and ingredients, and their labeling, do not require FDA approval.”

“There’s one exception: color additives (other than coal-tar hair dyes), which need to be approved by the FDA for their use.”

A note on the data

The records here come from openFDA, which says:

“Do not rely on openFDA to make decisions regarding medical care.”

Every entry links FDA's own database record and decision document, which are the authority. See how we built this.

Questions