Overview
All forms completed during the initial IDE submission process must be assembled into one IDE application packet. The forms must be submitted electronically (eCopy) through the CDRH Portal (Center for Devices and Radiological Health Customer Collaboration Portal).
Submitting Your Application:
Step1
Review FDA eCopy Guidance
What are the general requirements for submitting an IDE application?
- IDE Submission Instructions: this document contains the necessary information to successfully submit an IDE application to the FDA.
What is an eCopy?
- An electronic copy (eCopy) is a duplicate device submission in electronic format of the previously required paper copy submission sent to the FDA. An electronic copy is not considered an electronic submission.
What is the FDA eCopy program for medical device submissions?
- FDA overview of eCopy Medical Device Submissions external site (opens in a new window)
- FDA guidance on eCopy Program for Medical Device Submissions external site (opens in a new window) (April 2020) provides details of the program and technical standards for eCopies.
Step2
Create an eCopy of your IDE Application
- The eSubmitter-eCopies Tool external site (opens in a new window) is a program that guides you through the steps of creating an eCopy and allows you to download a formatted eCopy onto a local drive. This quick reference guide external site (opens in a new window) may be used as guidance.
- For detailed guidance, see the full eSubmitter User Manual external site (opens in a new window)
- Alternatively, you may review the FDA guidance on eCopy Program for Medical Device Submissions external site (opens in a new window) (April 2020), which provides technical standards for creating eCopies manually (review pages 17-29 carefully).
Step3
Submit a Copy of your IDE Application to the CDRH Portal
- Review FDA guidance: Send and Track Medical Device Premarket Submissions Online: CDRH Portal external site (opens in a new window) which includes tips for avoiding an eCopy hold, common errors, and contacts for questions.
- Create a user account external site (opens in a new window) for the CDRH Portal
What Happens After an IDE Submission?
FDA Action
- Acknowledgment of Receipt: FDA will notify the sponsor via email of the date it receives an IDE application.
- Information Requests: FDA may request additional information about an investigation. The sponsor may provide the requested information or the sponsor may treat such a request as a disapproval of the application and request a hearing in accordance with 21 CFR 16.
- Clinical Hold:
- FDA may prohibit the sponsor of an investigation from conducting the investigation (referred to "clinical hold') if an approved IDE represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the subjects involved.
- The sponsor of an IDE that is on clinical hold may request by writing to FDA to remove the clinical hold. Any such request shall include sufficient information to support the removal of such clinical hold.
- Outcomes: FDA may approve, approve with modification, or disapprove an IDE application.
- See this page external site (opens in a new window) for the reasons why FDA may disapprove or withdraw approval of an IDE application.
For more information, see the guidance "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations external site (opens in a new window) ."
Sponsor-Investigator Initiates the IDE Protocol
- A significant risk clinical investigation of a medical device may begin after the FDA approves an IDE for the investigation and the IRB approves the study.
- An investigation may begin 30 days after FDA receives the IDE application for the investigation of a device if IRB approval has been obtained unless FDA notifies the sponsor that the investigation may not begin.
- IRB Notification: Best practice is for the Sponsor-Investigator to submit the written FDA confirmation to the reviewing Institutional Review Board (IRB). For the UCSF IRB, upload the letter with the IRB application iRIS under the "Other Study Documents" section.