Establishment Registration & Device Listing - Food and Drug ...
5 days ago · Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
Drug Approvals and Databases | FDA
Sep 24, 2025 · Product-Specific Guidances for Generic Drug Development Database More Information Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and …
FDA Industry Systems
Oct 31, 2023 · FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications.
www.accessdata.fda.gov
Access the FDA's Center for Drug Evaluation and Research resources, including drug approvals, databases, and regulatory information.
FDA Dashboards - Inspections
FDA does not issue CGMP certificates at the conclusion of an inspection. Instead, this dashboard provides the outcomes, including classification and other details, of a firm’s most recent...
510 (k) Premarket Notification - Food and Drug Administration
5 days ago · A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device …
Product Classification - Food and Drug Administration
5 days ago · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. learn more...