Compilation of IDE Resources

• IDE Definitions and Acronyms
• IDE Definitions
• IDE Tracking Improvements
• UCSF Roles and Responsibilities for Compliance with FDA Regulations Pertaining to Clinical Research

See FDA guidance for background on device classification:

• Frequently Asked Questions About Medical Devices
• FAQs about Investigational Device Exemption
• Significant Risk and Nonsignificant Risk Medical Device Studies
• In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
• Device Software Functions Including Mobile Medical Applications
• General Wellness: Policy for Low-Risk Devices
• Classify Your Medical Device
• How to Study and Market Your Device

Search FDA Medical Device Databases for similar devices:

1. 510K cleared database
2. 510K exempt database
3. PMA database
4. De Novo database

UCSF Tool: IDE Device Checklist

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (June 2023)
• Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Final Guidance for Industry and CDRH Staff
• Early Feasibility Studies (EFS) Program

FDA Guidance

• IDE Application
• IDE Cover letter
• IDE Informed Consent
• Checklist for IDE Applications

Templates & Forms

• FDA Form 3514 - CDRH Premarket Review Submission Cover Sheet
• IDE Application Cover Letter 
• IDE Application Template
• IDE Protocol Template An alternative template protocol can be found here from the NIH National Institute on Aging.
• FDA Form 3454 - Certification: Financial Interest and Arrangements of Clinical Investigator
• FDA Form 3455 - Disclosure: Financial Interest and Arrangements of Clinical Investigators
• Informed Consent - see the UCSF IRB Consent Templates

Submitting the Initial IDE

• eCopy Medical Device Submissions
• eCopy Program for Medical Device Submissions (April 2020)
• eSubmitter-eCopies Tool page includes a quick reference guide and video tutorials.
• eSubmitter User Manual
• Send and Track Medical Device Premarket Submissions Online: CDRH Portal
• Create a user account for the CDRH Portal
• FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations

• IDE Reports
• Informal IDE Progress Report
• Formal IDE Progress Report
• IDE Records
• Sponsor's Responsibilities for Significant Risk Device Investigations
• Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff