Advertisement The National Law Review recently published an article by Hae Park-Suk and Lynn C. Tyler, M.S. of Barnes & Thornburg LLP regarding New FDA Final Guidance: Advertisement The FDA recently issued two final medical device guidance documents titled, “Refuse to Accept Policy for 510(k)s” and “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).” Draft versions of these two guidance … Continue reading FDA Issues Final Guidance on Refuse to Accept Policy for 510(k)s and Premarket Approval Applications (PMAs): Food, Drug & Device Law Alert