You may take seen words like this on a website selling a medical device in the Us, sometimes even with an FDA logo:

  • FDA Registered
  • FDA Certified
  • FDA Registration Document

Such words may be used to mislead y'all. Is that the same affair equally FDA canonical, FDA cleared, or FDA authorized? The short answer is NO. Here's why.

FDA Registration

Owners or operators of places of business (also chosen establishments or facilities) that are involved in the production and distribution of medical devices intended for employ in the U.s.a. are more often than not required to register annually with the FDA.

It's important to sympathise:

When a facility registers its establishment and lists its devices, the resulting entry in the FDA's registration and listing database does not denote approval, clearance, or say-so of that facility or its medical devices.

For more details:

  • For data on medical device institution registration, see How to Study and Market place Your Device > Device Registration and Listing.
  • For data on FDA institution registration in general, see FDA Basics for Manufacture > Registration and Listing.

Are there FDA Certificates?

When a business involved in the production and distribution of medical devices intended for utilize in the U.s.a. registers with the FDA, they exercise not receive a certificate from the FDA.

Information technology'south important to empathize:

The FDA does not issue any type of device registration certificates to medical device facilities.

In addition, the FDA does not "certify" registration information for businesses that have registered and listed.

An example of a misleading registration certificate, with FDA logo.

Instance of a Fraudulent Certificate

Misleading FDA Registration Certificates

Some firms sell medical devices in the United States alongside "FDA registration certificates," such every bit the sample certificate depicted here.

These certificates often take the look of an official government document and may include the FDA logo. However, FDA does not event device registration certificates.

Firms that misleadingly brandish certificates alongside information near and photos of a device for auction in the United States to imply review or approval by FDA of the device misbrand the device in violation of the Federal Food, Drug, and Cosmetic Act.

Related data: FDA Calls on Certain Firms to Stop Producing and Issuing Misleading "FDA Registration Certificates"

To report suspected misuse of a registration certificate, please refer to Reporting Allegations of Regulatory Misconduct.

How Practise Yous Know if the FDA Canonical, Cleared, or Authorized a Medical Device?

The FDA provides several means for yous to check if the FDA approved or cleared a medical device or, as described below, if the FDA authorized the device to be used during a public health emergency.

Cheque for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalog of approved and cleared medical device information from the FDA.

To search for FDA-approved or FDA-cleared products by device proper name or company proper noun:

  1. Go to the Devices@FDA Database.
  2. In the Enter a search term in the space below field, type the proper name of the device or the company name. You tin type the exact name of a specific device or a generic proper noun for a category of devices (such equally pacemaker).
  3. Click Search.

Screenshot of the Devices@FDA search page. The search term entered is pacemaker, and the user is clicking on the search button.

Example: Search for Pacemaker

Check for Products in the De Novo Database: The FDA may review medical devices through the De Novo premarket review pathway, a regulatory pathway for depression- to moderate-risk devices of a new blazon. A device reviewed through this pathway may be authorized for marketing in the U.s.a.. The term "De Novo" is Latin for "new."

To search for products past device name or company name:

  • Go to the Device Classification Under Section 513(f)(2)(De Novo) database.
  • Do one of the following:
    • In the Device Name field, type the device name and click Search.
    • In the Requester Name field, blazon the visitor name and click Search.

Screenshot of the De Novo Database. Device name entered is hearing aid, requester name is blank, and the user is clicking on the search button.

Example: Search for Hearing Aids

Check for Emergency Use Authorizations: In certain types of public health emergencies, such as during the COVID-19 pandemic, when the Secretarial assistant of Health and Human Services declares that circumstances be justifying the authorization of emergency utilise of medical devices, the FDA may consequence an Emergency Use Authorization (EUA) to qualify unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, care for, or forbid serious or life-threatening diseases or weather condition when certain criteria are met. This can help provide more than timely access to critical medical devices that may aid during the emergency when there are no adequate, canonical, and available options.

To check medical device EUAs, go to Emergency Use Authorizations for Medical Devices.