• Organization: U.S. Department of Health & Human Services
• Updated: 2025-07-16

The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

The CDRH FOIA electronic reading room contains frequently requested information via the Freedom of Information Act from the Center for Devices and Radiological Health.

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• Organization: U.S. Department of Health & Human Services
• Updated: 2009-12-31

This database contains historical information about CDRH Advisory Committees and Panel meetings through 2008, including summaries and transcripts.

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

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),...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2025-07-16

This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to the level of CDRH...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA)...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2025-07-16

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...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2021-01-19

This blog post was posted by Kevin Duvall on January 19, 2021. It was written by Kristen Honey, Chief Data Scientist and Senior Advisor to the Assistant Secretary for Health (ASH), U.S. Department...

• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

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)...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering systems such as the National Drug...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2025-07-16

Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the releasable...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

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)...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-10-31

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...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

This database contains a list of classified medical device recalls since November 1, 2002

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2025-07-16

This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-13

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002. The primary goal for MedSun is to work collaboratively with the clinical community to identify,...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of Radiology (ACR), and the States of...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

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...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

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

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