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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,... -
Orange Book
The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act and provides... -
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... -
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... -
Establishment Registration & Device Listing
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for... -
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products. -
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... -
Approved Animal Drug Products (Green Book)
On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions, the Act... -
Dissolution Methods Database
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution... -
Enforcement Reports
Whereas not all recalls are announced in the media or on our Recalls press release page, all recalls montiored by FDA are included in FDA's weekly Enforcement Report once they... -
NHRIC (National Health Related Items Code)
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... -
CDRH Inspections Database
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present. -
Blood Establishment Registration Database
This application provides information for active, inactive, and pre-registered firms. Query options are by FEI, Applicant Name, Establishment Name, Other Names, Establishment... -
Recalls of Food and Dietary Supplements
Food producers recall their products from the marketplace when the products are mislabeled or when the food may present a health hazard to consumers because the food is... -
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... -
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... -
Mammography Facilities
The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of Radiology (ACR),... -
Recalls of Medical Devices
This database contains a list of classified medical device recalls since November 1, 2002 -
Food Code Reference System
The Food Code Reference System (FCRS) is a searchable database that provides access to FDA�s interpretative positions and responses to questions related to the FDA Food Code.... -
Human Cell and Tissue Establishment Registration Public Query
This application provides Human Cell and Tissue registration information for registered, inactive, and pre-registered firms. Query options are by Establishment Name,...
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