Overview
The Sponsor-Investigator submits an IDE Application to FDA that includes the components listed here.
IDE Submission Components
- FDA Form 3514 - CDRH Premarket Review Submission Cover Sheet external site (opens in a new window)
- IDE Cover Letter external site (opens in a new window)
- IDE Application Template external site
(opens in a new window)
- It is recommended to use and refer to Appendices throughout the IDE Application to provide further detail on specific sections (e.g., study protocol, device manual, investigator's agreement, monitoring plan)
- If cross-referencing certain parts of the IDE application with a previous submission from the device's sponsor to fulfill IDE application requirements, provide the Authorization/ Rights of Reference letter as an appendix.
- Example Investigator's agreement
- IDE Protocol Template external site (opens in a new window)
- 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)
FDA Guidance Documents
The following FDA documents provide an overview of the IDE application process:
- IDE Application external site (opens in a new window) : Addresses required elements; suggested content; suggested format; common problems with IDE submissions.
- IDE Cover letter external site (opens in a new window) : Suggested content
- Checklist external site (opens in a new window) for IDE Applications
Other helpful documents:
- IDE Definitions and Acronyms external site (opens in a new window)
- IDE Financial Disclosure external site (opens in a new window)
- 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)
- IDE Informed Consent external site (opens in a new window)