NEWS

Stay up to date with the latest news and announcements in your industry.

 

Hold everything! There’s a guidance for relying on clinical data from wearables?

Without much ado, late last month FDA released a draft revision of “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers – Guidance for Industry.” And the Questions and mostly Answers throughout the draft guidance are, in many ways, just as long and as complex as the document title.

read more