This past July, the FDA issued a draft guidance on how it might regulate certain medical apps. The legal implications of the proposed guidelines is the subject of the most recent entry in the HIMSS/AMDIS Physician Community Podcast Series, hosted by Dr. Marlowe Schaeffer-Polk, an attorney, physician and co-founder of Medlawguard, and Mr. John Steinbach, Chief Technology Officer and co-founder of...
By Bradley Merrill Thompson, Epstein Becker & Green, P.C.
To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, a middle and an end. They paint an entire picture. Unfortunately, reading the MDDS rule is like reading just the middle of the story --...
