AccessGUDID (Global Unique Device   Identification Database)

This database contains key device identification   information submitted to the FDA about medical devices that have Unique   Device Identifiers (UDI).

Daily

Advisory   Committee/Panel Meetings - CDRH

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

No longer   being updated

CFR   Title 21 - Food and Drugs

This database contains the most recent revision   from the Government Printing Office (GPO) of the Code of Federal Regulations   (CFR) Title 21 - Food and Drugs.

Annually

Clinical   Laboratory Improvement Amendments (CLIA)

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.

Weekly

CLIA   Currently Waived Analytes 

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).

Monthly

De Novo

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

Weekly

FDA   Certified Mammography Facilities

A searchable listing by state and zip code of all   mammography facilities certified by the Food and Drug Administration (FDA) as   meeting baseline quality standards for equipment, personnel and practices   under the Mammography Quality Standards Act of 1992 (MQSA).

Weekly

Humanitarian   Device Exemption (HDE)

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

Weekly

IVD   Home Use Lab Tests (Over The Counter) Tests

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

Weekly

MAUDE   (Manufacturer and User Facility Device Experience)

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.

Weekly

MDR   (Medical Device Reporting)

This database allows you to search the CDRH's   database information on medical devices which may have malfunctioned or   caused a death or serious injury during the years 1992 through 1996.

No longer   being updated

Premarket   Approvals (PMA)

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. This database may be searched by a variety of   fields and is updated once a week.

Weekly

Premarket   Approval (PMA) Summary Review Memos for 180-Day Design Changes

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.

Weekly

Premarket   Notifications (510(k)s)

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. This database of releasable 510(k)s can be   searched by 510(k) number, applicant, device name or FDA product code.    Summaries of safety and effectiveness information is available via the web   interface for more recent records. The database is updated once a week.

Weekly

Product   Classification

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 regulation of a given device.

Weekly

Radiation-emitting   Electronic Product Codes

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.

Weekly

Radiation Emitting Product   Corrective Actions and Recalls

This database provides descriptions of   radiation-emitting products that have been recalled under an approved   corrective action plan to remove defective and noncompliant products from the   market. Searches may be done by manufacturer name, performance standard,   product name, description, or date range.

Weekly

Recalls   of Medical Devices

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

Frequently   as items become available

Registration   & Listing

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. Note: This database is updated once   a week.

Weekly

Total   Product Life Cycle (TPLC)

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. You can search   the TPLC database by device name or procode to receive a full report about a   particular product line.

Weekly

FDA   Recognized Consensus Standards

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.

Quarterly

X-Ray   Assembler Data

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 information   submitted including  Equipment Location, General Information and   Component Information. Note: Data does not include dental system   installations. 

Annually