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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
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
FDA Recognized Consensus Standards
U.S. Department of Health & Human Services —
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information... -
Federal
CDRH Inspections Database
U.S. Department of Health & Human Services —
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present. -
Federal
FDA Data Inventory
U.S. Department of Health & Human Services —
An inventory of all FDA Datasets -
Federal
POCA -Phonetic Orthographic Computer Algorithm
U.S. Department of Health & Human Services —
POCA is a software that produces a data set used internally to assess the safety, and feasibility of proposed proprietary drug names. FDA product name safety... -
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... -
Federal
Hydrolyzed Vegetable Protein Containing Products Recalls
U.S. Department of Health & Human Services —
This list includes products subject to recall in the United States since February 2010 related to hydrolyzed vegetable protein (HVP) paste and powder distributed by... -
Federal
Approved Risk Evaluation and Mitigation Strategies
U.S. Department of Health & Human Services —
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to... -
Federal
Mammography Facilities
U.S. Department of Health & Human Services —
The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of... -
Federal
CFSAN Knowledge Management System
U.S. Department of Health & Human Services —
This system supports the Information Center's Help Desk capabilities, and reports can be exported. -
Federal
Post-Approval Studies
U.S. Department of Health & Human Services —
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a...