Medical Devices

Medical Device Databases

TitleDescriptionUpdatedMore Information
Advisory Committee/Panel Meetings - CDRHThis database contains historical information about CDRH Advisory Committees and Panel meetings through 2008, including summaries and transcripts.No longer being updatedFDA Advisory Committees and Meeting Materials
CDRH Inspections DatabaseThe CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.WeeklyMore CDRH Inspections Database
CFR Title 21 - Food and DrugsThis database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs.AnnuallyMore About 21CFR
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.WeeklyClinical Laboratory Improvement Amendments - Download Data
CLIA Currently Waived Analytes disclaimer icon 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).MonthlyCLIA Waivers
De NovoDe 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 FacilitiesA 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 
IVD Home Use Lab Tests (Over The Counter) TestsSearchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDAWeeklyMore about Home Use Lab Tests
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.WeeklyFile Description for the CDRH Releasable (Approved) PMAs
Premarket Approval (PMA) Summary Review Memos for 180-Day Design ChangesA 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.WeeklyMore about Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
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 ClassificationThis 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.WeeklyMore about Product Code Classification Database
Radiation-emitting Electronic Product CodesThis 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 RecallsThis 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.WeeklyMore About Corrective Actions
Recalls of Medical DevicesThis database contains a list of classified medical device recalls since November 1, 2002Frequently 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.WeeklyMore about TPLC
FDA Recognized Consensus StandardsThis 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 DataFederal 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. AnnuallyX-Ray Assembler Data File

 

Page Last Updated: 08/12/2014
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