Day: October 27, 2016

Not many people know that FDA has an Emerging Sciences Working Group (ESWG) for the last year consisting of 15 leaders from various departments who brainstorm about innovative new technologies being developed but have not yet reached FDA review stage. All new innovations start as ideas which over time evolve through development and testing to product that … Read more

This week FDA released a new form specifically designed for whistleblowers in the medical device industry. Anyone can report alleged regulatory misconduct directly to FDA. The kind of misconduct FDA is looking for are failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow GMP, or off-label promotion. The examples cited by … Read more