ITHS-WRF Fellows

✽DynaMed

✽UpToDate

✽How Drugs Are Developed and Approved by the FDA: Current Process and Future Directions (2014) - short article

✽Drugs@FDA
-- database of approval documents for FDA-approved drug products: new molecular entities, generics, and many biologics

✽Medical Devices: US Medical Device Regulation (2015) - short article written by FDA authors

✽FDA Overview of Device Regulation - FDA website

✽FDA Premarket Approval - for Class III devices - FDA website

✽FDA Premarket Notification (510(k)) - for substantially equivalent devices - FDA website

✽FDA Premarket Approval (PMA) Database
--Class III medical devices approved for marketing by FDA (CDRH) based on scientific and regulatory review of safety and effectiveness. 
--Search for products by name or classification

✽FDA 510(k) Database
--Premarketing submissions made to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device that is NOT subject to premarket approval
--Search for products by name or classification

✽Medicare Provider Utilization and Payment Data - from the Centers for Medicare and Medicaid Services

✽Current Procedural Terminology (CPT) Codes - from the Centers for Medicare and Medicaid Services

✽Company websites

✽Business Source Complete

✽Lexis-Nexis Academic

✽UW Libraries Business Research Guide