IDE Background
IDE Device Classifications and Determinations
See FDA guidance for background on device classification:
- Frequently Asked Questions About Medical Devices external site (opens in a new window)
- FAQs about Investigational Device Exemption external site (opens in a new window)
- Significant Risk and Nonsignificant Risk Medical Device Studies external site (opens in a new window)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions external site (opens in a new window)
- Device Software Functions Including Mobile Medical Applications external site (opens in a new window)
- General Wellness: Policy for Low-Risk Devices external site (opens in a new window)
- Classify Your Medical Device external site (opens in a new window)
- How to Study and Market Your Device external site (opens in a new window)
Search FDA Medical Device Databases for similar devices:
- 510K cleared database external site (opens in a new window)
- 510K exempt database external site (opens in a new window)
- PMA database external site (opens in a new window)
- De Novo database external site (opens in a new window)
UCSF Tool: IDE Device Checklist external site (opens in a new window)
Q-Submission (Pre-IDE) Guidance
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program external site (opens in a new window) (June 2023)
- Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Final Guidance for Industry and CDRH Staff external site (opens in a new window)
- Early Feasibility Studies (EFS) Program external site (opens in a new window)
IDE Initial Application
FDA Guidance
- IDE Application external site (opens in a new window)
- IDE Cover letter external site (opens in a new window)
- IDE Informed Consent external site (opens in a new window)
- Checklist external site (opens in a new window) for IDE Applications
Templates & Forms
- FDA Form 3514 - CDRH Premarket Review Submission Cover Sheet external site (opens in a new window)
- IDE Application Cover Letter external site (opens in a new window)
- IDE Application Template external site (opens in a new window)
- IDE Protocol Template external site (opens in a new window) An alternative template protocol can be found here external site (opens in a new window) from the NIH National Institute on Aging.
- FDA Form 3454 - Certification: Financial Interest and Arrangements of Clinical Investigator external site (opens in a new window)
- FDA Form 3455 - Disclosure: Financial Interest and Arrangements of Clinical Investigators external site (opens in a new window)
- Informed Consent - see the UCSF IRB Consent Templates external site (opens in a new window)
Submitting the Initial IDE
- eCopy Medical Device Submissions external site (opens in a new window)
- eCopy Program for Medical Device Submissions external site (opens in a new window) (April 2020)
- eSubmitter-eCopies Tool external site (opens in a new window) page includes a quick reference guide external site (opens in a new window) and video tutorials.
- eSubmitter User Manual external site (opens in a new window)
- Send and Track Medical Device Premarket Submissions Online: CDRH Portal external site (opens in a new window)
- Create a user account external site (opens in a new window) for the CDRH Portal
- FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations external site (opens in a new window)
IDE Reports and Records
- IDE Reports external site (opens in a new window)
- Informal IDE Progress Report external site (opens in a new window)
- Formal IDE Progress Report external site (opens in a new window)
- IDE Records external site (opens in a new window)
- Sponsor's Responsibilities for Significant Risk Device Investigations external site (opens in a new window)
- Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff external site (opens in a new window)