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FDA IDE Submission Consulting for Obtaining an Investigational Device Exemption (21 CFR Part 812)



If your company is developing a new medical device, and clinical studies will be required, the first step is determining whether your proposed clinical study is deemed to be of “significant or nonsignificant” risk. If your study is determined to pose a significant risk, an FDA Investigational Device Exemption (IDE) and Instituational Review Board (IRB) approval will be required before commencing the study. If it’s determined to be nonsignificant, only IRB approval is required.

An approved IDE is required to collect safety and effectiveness data required to support a Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE), or a Premarket Notification [510(k) submission to FDA.  Clinical investigations in the United States must be approved prior to conducting a clinical study on an investigational device on human subjects. The IDE rules are spelled out in 21 CFR Part 812.

So what exactly is “substantial risk” in the eyes of FDA?

Implants and devices that sustain human life are obviously substantially risky but the FDA is less clear on all other devices. Getting this determination right the first time is critical to prevent delays when initiating significant risk studies. Our FDA experts can assist you.

Preventing the rejection of your IDE application

The FDA can torpedo your IDE application for many reasons. Some are obvious and preventable such as missing or inaccurate information. Other reasons include inadequate reporting of prior investigations, poorly conceived investigational plans or incomplete design and manufacturing description.  Our FDA consultants are experienced in helping companies navigate these challenges. We can minimize the risk of rejection by helping you craft your IDE application so FDA is less likely to rule that your device risks outweigh its benefits, it is perceived to be ineffective, or your proposed investigation is scientifically unsound.

Ways we can help:

  • Pre-submission meetings with FDA
  • Study risk determination
  • Early feasibility studies (EFS)
  • Review and preparation of IDE progress reports
  • Informed consent form review and planning

Let our team conduct a gap analysis against the FDA IDE checklist 

Submitting an IDE application to FDA without first soliciting their input is like buying a used car based solely on photos. It’s not recommended. FDA has published an exhaustive 35-point checklist which should be carefully followed but one of the best ways to improve your odds of a successful IDE application is to schedule a pre-submission meeting with FDA. Our team has extensive experience helping medical device companies plan for pre-submission meetings to ensure that you get answers to critical questions such as your proposed study design.

Contact us for more information on FDA IDE support

Oriel STAT A MATRIX has been focused on FDA compliance for 50+ years. We have trained and advised regulatory professionals at thousands of companies. Give us a call or contact us online to start a discussion about how we may assist you. 

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