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