Adverse Event Reporting
System
Description: The Adverse Event Reporting System (AERS) is a
computerized information database designed to support the FDA's post-marketing
safety surveillance program for all approved drug and therapeutic biologic
products.
Agents
for Medical Devices
Description: Owners or operators of places of business
(establishments) that are involved in the production and distribution of
medical devices intended for use in the United States (U.S.) are required to
register annually with the FDA.
Approved
Animal Drug Products
Description: Database of approved animal drug products.
Approved
Animal Drug Products - Advanced Search
Description: Advanced search of database of approved animal
drug products.
Approved Drug
Products
Description: Approved Drug
Products with Therapeutic Equivalence Evaluations.
Assembler
Database
Description: Federal regulations (Section
21 CFR 1020.30(d)) require that an assembler who installs one or more
certified components of a diagnostic x-ray system submit a report of assembly
(Form
FDA 2579) to FDA within 15 days following the completion of the assembly.
Biological
Product Deviation Reports (BioDev)
Description: Login required to access CBER reports: Blood
Establishment Registration (Form FDA 2830); Tissue Establishment Registration
(Form FDA 3356); Biological Product Deviation Reporting (Form FDA 3486).
CDRH
Document Database
Description: Center for devices and radiological health
documents.
CFR
Title 21 - Food and Drugs
Description: The Code of Federal Regulations (CFR) is a
codification of the general and permanent rules published in the Federal
Register by the Executive departments and agencies of the Federal Government..
Title 21 of the CFR is reserved for rules of the Food and Drug Administration.
Each title (or volume) of the CFR is revised once each calendar year. A
revised Title 21 is issued on approximately April 1st of each year
and is usually available here several months later.
Clinical
Laboratory Improvement Amendments
Description: Congress passed the Clinical Laboratory
Improvement Amendments (CLIA) in 1988 establishing quality standards for all
laboratory testing to ensure the accuracy, reliability and timeliness of
patient test results regardless of where the test was performed.
Drug Firm
Annual Registration Status
Description: Firms manufacturing drug products must register
the site where the product was made within 5 days of commercial distribution.
Drug Information - Human
Drugs - CDER
Description: Helping you make informed decisions about using
medicines.
Drugs@FDA
Description: Search by Drug Name, Active Ingredient, or
Application Number
Establishment
Registration
Description: Owners or operators of places of business
(establishments) that are involved in the production and distribution of
medical devices intended for use in the United States (U.S.) are required to
register annually with the FDA.
Federal
Register Notices and Documents
Description: Search the Federal Register for document from
1967 to Present.
Foods -
the Seafood List
Description: "The Seafood List" is a compilation of
existing acceptable market names for imported and domestically available
seafood as well as scientific names, common names, and known vernacular or
regional names.
Good
Guidance Practice
Description: Good Guidance Practice (GGP) documents are
documents prepared for CDRH staff, regulated industry and the public that
relate to: the processing, content, and evaluation of regulatory submissions;
the design, production, manufacturing, and testing of regulated products; the
inspection and enforcement procedures.
Inactive
Ingredient Search for Approved Drug Products
Description: According to 21 CFR 210.3(b)(8), an inactive
ingredient is any component of a drug product other than the active
ingredient. Only inactive ingredients in the final dosage forms of drug
products are in this database.
Interstate
Certified Shellfish Shippers
Description: The Interstate Certified Shellfish Shippers List
(ICSSL) is published monthly for the information and use by food control
officials, seafood industry and other interested persons.
Mammography
Quality Standards
Description: Information for
mammography facility personnel, inspectors, and consumers about the
implementation of the Mammography Quality Standards Act of 1992 (MQSA)
Medical
Device Adverse Events (MAUDE)
Description: MAUDE data represents reports of adverse events
involving medical devices. The data consists of voluntary reports since June
1993, user facility reports since 1991, distributor reports since 1993, and
manufacturer reports since August 1996. MAUDE may not include reports made
according to exemptions, variances, or alternative reporting requirements
granted under 21 CFR 803.19.
Medical
Device Approvals
Description: The products listed on this page include some of
the newest medical technology available. Each product listing contains
information about what medical uses the device is approved for, when it can be
used, and when it should not be used.
Medical
Device Listing
Description: Most 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.
Medical
Device Reporting
Description: Medical Device Reporting (MDR) is the mechanism
for the Food and Drug Administration to receive significant medical device
adverse events from manufacturers, importers and user facilities, so they can
be detected and corrected quickly.
National Drug
Code Directory
Description: Search by proprietary name, active ingredient,
application number, NDC number or firm name.
National
Health Related Items Code (NHRIC)
Description: 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 Code (NDC)
or Universal Product Code (UPC).
Oncology
Tools
Description: Welcome to the FDA Oncology Tools
web site! Oncology Tools contains a variety of information related to
cancer and approved cancer drug therapies.
Postmarketing Study
Commitments
Description: This Web site is intended to provide information
to the public on postmarketing study commitments, also called phase 4
commitments.
Premarket
Approval (PMA)
Description: The Medical Device Amendments of 1976 to the
Federal Food, Drug, and Cosmetic Act (the act) established three regulatory
classes for medical devices.
Product
Code Builder
Description: A new tool is
available to you for assistance in building valid FDA product codes. The
Product Code Builder Application will guide you through an easy and user
friendly selection process that will assist you in locating and building a
product code.
Products
Classification
Description: The product classification database contains
medical device names and associated information developed by the Center for
Devices and Radiological Health (CDRH) in support of its mission.
Recognized
Consensus Standards
Description: Search for recognized consensus standards.
Vaccine Adverse Event Reporting System (VAERS)
Description: The Vaccine Adverse Event Reporting System (VAERS)
is a cooperative program for vaccine safety of the Centers for Disease Control
and Prevention (CDC) and the Food and Drug Administration (FDA).
Warning Letters
Description: This page is designed to simplify the search for
Warning Letters and Responses.
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