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Federal
Premarket Notifications (510(k)s)
U.S. Department of Health & Human Services —
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... -
Federal
Establishment Registration & Device Listing
U.S. Department of Health & Human Services —
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices... -
Federal
Total Product Life Cycle (TPLC)
U.S. Department of Health & Human Services —
The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases... -
Federal
Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)
U.S. Department of Health & Human Services —
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the... -
Federal
Plainview Milk Cooperative Ingredient Recall
U.S. Department of Health & Human Services —
This list includes products subject to recall in the United States since June 2009 related to products manufactured by Plainview Milk Products Cooperative. -
Federal
Code of Federal Regulations Title 21
U.S. Department of Health & Human Services —
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. -
Federal
IVD Home Use Lab Tests (Over The Counter) Tests
U.S. Department of Health & Human Services —
Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA -
Federal
Peanut Product Recalls
U.S. Department of Health & Human Services —
This list includes human and pet food subject to recall in the United States since January 2009 related to peanut products distributed by Peanut Corporation of America. -
Federal
CFSAN Web Modules
U.S. Department of Health & Human Services —
This system shares public data that can be downloaded. -
Federal
Fraudulent 2009 H1N1 Influenza Products
U.S. Department of Health & Human Services —
This list is intended to alert consumers about Web sites that are or were illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009... -
Federal
Public Search for Adverse Events (FOIA)
U.S. Department of Health & Human Services —
Public access allowing for public search of the FDA Adverse Events Database -
Federal
Fraudulent 2009 H1N1 Influenza Products Widget
U.S. Department of Health & Human Services —
This list is intended to alert consumers about Web sites that are or were illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009... -
Federal
FDA Plainview Milk Cooperative Ingredient Recall
U.S. Department of Health & Human Services —
Contains data for the FDA Plainview Milk Cooperative Ingredient Recall since June 2009. -
Federal
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
U.S. Department of Health & Human Services —
A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved... -
Federal
FDA Peanut-Containing Product Recall
U.S. Department of Health & Human Services —
The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...