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Links


IND Resources

  • Industry Guidance for Providing Regulatory Submissions to CBER in Electronic Format

IDE Resources

  • CDRH Learn: a compilation of educational modules presented by FDA/CDRH staff to provide device development information
  • Catalog of Regulatory Science Tools to Help Assess New Medical Devices

Monitoring Resources

  • DSMB Training Manual
  • NIA guidance on Data and Safety Monitoring
  • NIDDK guidance on Data and Safety Monitoring Plans
  • Guidelines for Developing a Data and Safety Monitoring Plan

Other Regulatory Resources

  • North Carolina Regulatory Affairs Forum (NCRAF): an association of regulatory affairs professionals
  • Regulatory Affairs Professional Society (RAPS): global organization for those involved with the regulation of healthcare and related products
  • List of Regulatory Acronyms/Abbreviations
  • List of Funding Agencies
  • PRIMR
  • FDA Pediatric Device Consortia Grants Program
  • 21 CFR Part 11
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These documents are provided for your personal use for educational purposes. They should not be considered official regulatory documents.
If you are submitting an IND or IDE to the FDA, expert guidance is suggested.
Last updated Apr 18 2022
Last updated Apr 18 2022
Site created and maintained by RTI International
Site created and maintained by
RTI International