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  4. Medical Device Databases
  1. Device Advice: Comprehensive Regulatory Assistance

Medical Device Databases

Title Description Updated More Information
522 Postmarket Surveillance Studies Program This database contains information about current 522 Postmarket Surveillance Studies. This database allows you to search 522 information by manufacturer or device information. Weekly More about 522
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 More about GUDID
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 No longer being updated FDA Advisory Committees and Meeting Materials
CDRH Export Certificate Validation (CECV) 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 results displayed include the facility name, certificate type, expiration date, certificate number, and the number of pages per certificate. Weekly    
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. Quarterly More 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. Weekly Clinical Laboratory Improvement Amendments - Download Data
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 CLIA Waivers
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  
Devices@FDA Devices@FDA is a catalog 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. Devices@FDA searches the following databases: Premarket Notifications (510(k)s) and Premarket Approvals (PMA). 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 More about Humanitarian Device Exemption (HDE)
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 More 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  
MedSun Reports 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.  Daily  MedSun Homepage
Post-Approval Studies (PAS) Database This database contains information about current Post-Approval Studies (PAS). Manufacturers required to conduct PAS must complete the study as a condition of approval. This database allows you to search PAS information by applicant or device information. This database is updated once a week. Weekly More about PAS
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 File Description for the CDRH Releasable (Approved) PMAs
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 More 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 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 More about Product Code Classification Database
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 More About Corrective Actions
Recalls of Medical Devices

This database contains Medical Device Recalls classified since November 1, 2002. Beginning January 3, 2017, the database may also include correction or removal actions initiated by a firm prior to review by the FDA. The status of the action 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 and provides contact information for customers with questions.  Therefore, the recall information posting date (“create date”) indicates the date FDA classified the recall, it does not necessarily mean that the recall is new.  CBER recall information is available here.

 Frequently as items become available More About Recalls
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  
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. 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. If a device requires a premarket submission before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE). Note: This database is updated weekly. Weekly More About Registration and Listing
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 More about TPLC
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.  No longer being updated X-Ray Assembler Data File


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