US FDA Investigational Device Exemption (IDE) 21 CFR 812

 IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.

IDE definition and GCP regulations are given in below figure.

Device Study Classification:

Common IDE Application (812.20) contents are listed below,

• Name and address of sponsor
• Report of prior investigations and investigational plan
• Manufacturing, processing, packing, and storage of device
• Investigator agreement
• List of the name, address, and chairperson of each IRB
• Participating institutions
• Charge for device
• Environmental assessment
• Labeling
• Subject materials including informed consent
• Additional information requested by FDA

Study Risk Determination:

Option 1:Study risk can be determined by sponsor and IRB reviews the sponsor’s determination

Option 2: Sponsor submits “Study Risk Determination” Q-Submission.

FDA issues letter indicating if study is

• Basic physiological research
• Exempt
• Not exempt: SR or NSR

Application process

1.Sponsor submits the IDE application too FDA CDRH's or CBER’s Document Control Center (DCC). FDA will send the acknowledgement letter IDE number: GYYxxxxx (e.g. G140001)

2.IDE sent to appropriate review division based on intended use

3.Lead reviewer assembles team of experts to review the application and make decision with management concurrence within 30 days

4.FDA issues a decision letter to the sponsor

Decision:

• Approval
• Approval with conditions
• Disapproval

IDE supplements: Any significant  changes in approved IDE may require IDE Supplements(812.35)

• Change in protocol
• Change in device

 Sponsor can submit Reports(812.150) of the following

• Annual progress
• Unanticipated adverse device effects
• Follow-up completion
• Current list of investigators
• Final report

References:

Investigational Device Exemption (IDE)) : https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide

Guidance:“FDA Decisions for IDE Clinical Investigations”

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279107.pdf