FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an IDE application for FDA approval. Although the majority of IDE applications are granted full approval, those with “outstanding issues” that would have previously been rejected may be issued a “conditional approval.”
The new guidance document explains the conditional approval process, which is intended to improve timeliness and efficiency in IDE submissions and allow FDA to approve clinical trials that may contain flaws but are otherwise not completely far-gone. While much of the final document mirrors the draft guidance, a significant difference is FDA’s decision to postpone the development of their Pre-Decisional IDE program, intended to accelerate the clinical assessment process.
To learn more about the new guidance, click here to read the guidance, or check out Alexander Gaffney’s full article on RAPS.org.