US FDA Pre-Investigational Device Exemption (Pre-IDE) Consulting

See all medical device clinical consulting services.

An Investigational Device Exemption (IDE) is required for risky investigations involving human study and certain other cases. Study sponsors seek IDE approval prior to initiating the investigation of a medical device or IVD. In order to obtain IDE approval from the FDA, the sponsor must submit an IDE application. Essentially, once attained, IDE approval signifies that the sponsor’s study application has been approved by the FDA and that all the requirements pursuant to 21 CFR 812 have been met.

The first step for a study sponsor is to determine whether or not the medical device is a significant risk device or a nonsignificant risk device because the IDE approval process is contingent upon the risk of the medical device or IVD. Significant risk device studies require FDA approval in addition to Institutional Review Board (IRB) clearance prior to initiation of human study, whereas nonsignificant risk device studies require only IRB approval before the commencement of clinical study. There are exceptions, however, where certain nonsignificant risk devices must follow the pathway of significant risk devices. Please note that the IRB is not affiliated with the FDA.

Pre-IDE Regulatory Pathway to FDA Approval

Emergo Group can assist with pre-IDE consulting. Our services include:

Pre-IDE submission: This is essentially a synopsis of the proposed clinical study protocol needed in order to obtain a pre-IDE meeting.
Pre-IDE meeting: This is the actual discussion on the above with the FDA.

In order to maintain IDE compliance, the sponsor must abide by specifications stipulated by the FDA on the following:

Labeling
Distribution
Informed Consent
Monitoring
Prohibitions
Records and Reports

The approval pathway for nonsignificant risk medical device studies is less stringent than the above process for significant risk device studies. In addition to the simplified approval process, once approval has been granted, sponsors have to conform to abbreviated IDE requirements.

Through our US and European consulting teams, Emergo Group is well equipped to assist medical device manufacturers and study sponsors through the FDA pre-IDE consulting process.