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MediRegs Device Regulation Library

The most complete research tool for regulatory guidelines including FDA medical device regulations

The Device Regulation Library 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 Library 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.

  • Enforcement materials, including access to FOI Services
  • Comprehensive collections of EIRs, 483s and Warning Letters back to the 1970s
  • 510(k) summaries back to 1996 (full text back to 1976)
  • Legislation, including U.S. Code and public laws
  • Code of Federal Regulations
  • Federal Register - FDA, CMS, OIG, HHS, PHS, CDC, FTC, DEA
  • Establishment registration and product listings
  • FDA and NIH manuals and guidelines
  • PMA summaries back to 1945 (full text back to 1976)
  • FDA Product Safety Information, (FOI Services' Medical Device Reports back to 1985)
  • Many other important documents and resources

Quick searches for critical information

The Device Regulation Library 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

 Simplify your FDA medical device regulations searching- contact us for more information