FDA produced a draft guidance on whether or not medical devices are fit to be tested on humans. The guidance is called “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs)”.
Per Alexander Gaffney of RAPS, the reasoning for this draft guidance is to provide “greater clarity for FDA staff and IDE sponsors and sponsor-investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human study.” Many times when a medical device is being tested, the risks and benefits are discovered during the trial instead of before. This guidance was created to help ensure the assurance and risk mitigation of a medical device when used in humans.
To see what else Alexander Gaffney says about the new guidance by FDA, continue reading here.