Investigational Device Exemption Application Consulting
An Investigational Device Exemption (IDE) is issued by the Food and Drug Administration to allow the use of investigational devices in human subjects. The IDE permits use of the device in a clinical investigation to evaluate the safety and/or efficacy of the investigational medical device.
A sponsor of a significant risk medical device study must submit a complete IDE application to the FDA. Since there are no preprinted forms for an IDE application, Methodize Inc. can ensure that your company's IDE application includes certain required information. Methodize Inc. will help you demonstrate that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects. Also, the IDE application must prove that important knowledge will be gained, the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.
The IDE application should assure the FDA that the device, all preclinical testing, and the investigational plan are described and provide adequate justification for the initiation of the clinical trial. One common mistake that many device companies make is submitting the IDE application prematurely. In these cases, there are three common areas that are frequently lacking in IDE applications:
- Inadequate report of prior investigations
- Inadequate investigational plan
- Inadequate/incomplete design and manufacture
Methodize Inc. can help you avoid the inadequacies mentioned above. We will take your company through the IDE application process, ensuring that you will gain approval by the FDA.
Email Methodize Inc. to receive a free proposal or for more information.
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