The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).

The FDA is establishing a unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use.

This searchable database contains valid (not expired) export certificates submitted electronically via CECATS (CDRH Export Certification Application and Tracking System) and issued by the Center for Devices and Radiological Health.

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for the Food and Drug Administration rules.

This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.

This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease Control and Prevention (CDC) prior to that date. 

CLIA-waived test systems are waived from certain CLIA laboratory requirements (42 CFR Part 493).

De novo provides a possible route to classify novel devices of low to moderate risk. This database contains de novo classification orders.

In 1997, the Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an alternate pathway to classify new devices into class I or II that had automatically been placed in class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. 

In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the act.

[email protected] is a database of cleared and approved medical device information from FDA. It includes links to the device summary information, manufacturer, approval date, user instructions, and other consumer information. 

[email protected] searches the following databases: Premarket Notifications (510(k)s) and Premarket Approvals (PMA).

A searchable listing of Humanitarian Device Exemption (HDE) Class III medical devices.

Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255).

Humanitarian Device Exemption (HDE) is a marketing application for a HUD (Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.

A searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA

MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters  (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals, patients, and consumers.

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.

The FDA may require a post-approval study (or studies) at the time of approval of a Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE) application to help ensure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device.

Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. 

An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device.

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. 

As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes.

Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.

The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains device names and their associated product codes. 

The name and product code identify the generic category of a device for the FDA. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.

This database contains product names and associated information developed by the Center for all products, both medical and non-medical, which emit radiation. 

It includes a three-letter product code, a descriptor for radiation type, applicable performance standard(s), and a definition for the code.

This database provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and non-compliant products from the market.

This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. 

The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. FDA recall classification may occur after the firm recalling the medical device product conducts and communicates with its customers about the recall.

This database consists of those national and international standards recognized by FDA, which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. 

Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs.  Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.

This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers. 

Generally, 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, 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.

The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases, including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. The TPLC database is refreshed as each of the individual data sources is updated.