The Device Regulation Suite provides all-in-one access to the massive volumes of regulatory guidelines related to medical device manufacturing, sale and use in the United States. Consolidated, web-based tools speed research on FDA medical device regulations, with easy searches through thousands of other federal publications, guidance documents, reports and other regulatory resources.
- Keep up with FDA medical device regulations
- Access data on thousands of devices, related products, and companies
- Receive continual updates on data from all key regulatory agencies
- Eliminate months of waiting for responses to Freedom of Information (FOI) requests.
One-stop access to complete FDA medical device regulations data and more
The Device Regulation Suite provides fast searches through the most complete collection of regulatory resources possible, including many not available on the Web. Resources span many agencies and document types.
- Code of Federal Regulations, including 21 CFR and many other titles, updated continuously
- Federal Register, updated daily, with archives back to 1991
- U.S. Code and public laws
- Import Alerts in a table sortable by date, alert number or title/description
- FDA device safety information
- Freedom of Information (FOI) Logs
- Press releases, speeches, testimonies and forms FDA manuals and guidance documents, including CDRH guidance back to 1992
- Warning and cyber letters
- Enforcement reports and court cases
- Many other important documents and resources
Quick Searches for Critical Information
The Device Regulation Suite makes it easy to get all the information you need using a single set of integrated, robust search tools.
- Easy Web links, extensive archives and fast searches save time and connect you quickly to key regulatory information.
- Automatic daily updates
- Easy searches from a single location
- Fast, easy-to-use search tools