What is an IDE?
An Investigational Device Exemption (IDE) is a regulatory mechanism used by FDA that allows a high risk medical device that hasn’t yet been approved or cleared for marketing to be used in a clinical study so that safety and effectiveness data can be collected. In this manner, sponsors can generate the clinical data that are often necessary to support a 510(k), De Novo Classification Request or a Premarket Approval (PMA) submission.
How to Prepare an IDE?
Following is a detailed description of the items to be included in an IDE submission for a medical device:
1.Complete report of prior investigations, including the following information.
1.1 Bibliography of publications, relevant to evaluation of safety and effectiveness of the device.
1.2 Published and unpublished adverse information.
1.3 Summary of all unpublished information.
1.4 Statement that non-clinical studies were conducted in compliance with good laboratory practice (GLP) or brief
statement of reason for noncompliance.
- Investigational Plan, including the following information:
2.1 Investigation Protocol describing in detail the design of the study.
2.2 Risk Analysis
2.3 Description of the device.
2.4 Monitoring procedures.
2.5 Informed consent materials.
- Manufacturing information.
- Investigator Agreements and List of Investigators participating in the study.
- IRB information, including review of investigation (if available).
- Environmental assessment.
- Labeling for the device.
FDA has published a Guideline with Suggested Format for IDE Submissions, including a checklist and content layout to help ensure submissions are complete and administratively correct (https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application).
Helpful tips when submitting an IDE Submission:
- Determine if you actually need an IDE, as an IDE is only required for clinical investigations of significant risk (SR) devices. If your medical device is nonsignificant risk (NSR), IRB approval alone will suffice.
- Follow FDA’s required elements and format published in the above guidance document to help ensure the submission is complete and administratively correct.
- Engage early with FDA through a Pre-Sub to discuss your proposed clinical protocol or risk classification. Early feedback can de-risk the IDE review and help expedite the IDE review process.
How we can help?
- Stein – Regulatory Affairs Consulting assists companies in preparing and submitting Investigational Device Exemption (IDE) submissions to obtain FDA approval of your Clinical Study to collect the safety and effectiveness data to support your eventual regulatory submission.
