Last week, the FDA released a new draft guidance document called Adaptive Designs for Medical Device Clinical Studies. While the title specifically calls out “medical device,” the document states the following:
This guidance does not apply to clinical studies of combination products or codevelopment of a pharmaceutical product with an unapproved diagnostic test. However, the underlying principles may be applicable to such studies.
So, even if you’re not part of a medical device company, it’s worth your time to review this draft document. We have 90 days to submit comments that will help shape the final version of this guidance, so don’t miss your chance to voice your opinion! The deadline is Monday, August 17, 2015 11:59 PM ET.
