FDA, NIH Propose New Clinical Trial Protocol Template for Investigational Device Exemptions (IDE)
The US Food and Drug Administration and the National Institutes of Health (NIH) have jointly proposed a new template for clinical trial sponsors to use for submitting Investigational Device Exemption (IDE) applications.
The agencies are seeking comment on the new protocol template through April 17, 2016.
The new template is intended to improve and speed up FDA and NIH reviews of IDE applications submitted through a better organized and more consistent medium. The template is based on the International Conference on Harmonisation’s E6 Good Clinical Practice guidance.
Together with Pre-Submission Consulting currently offered by the FDA, a more uniform protocol template for IDE applications could do much to reduce complexities and unnecessary delays for medical device manufacturers in need of clinical trials.
For more information on clinical trial requirements for medical devices in the US, please see our whitepaper on FDA clinical quality assurance requirements.