Jeffrey Jacobs alleges that Idaho’s Pocatello Hospital violated the False Claims Act because of physician recruitment contracts that were overly generous to his practice group. Jeff should know because he was recruited under one of the contracts and worked for the group for three years. According to the …
OMG: Kim Kardashian Prompts FDA Warning Letter
August 11, 2015 Leave a Comment
Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian devotee apparently works at the U.S. Food and Drug Administration (FDA), which sent a …
Good News for Hospitals: FDA Eases Up on Medical Device Data Systems
June 20, 2014 Leave a Comment
A couple of years ago, FDA reclassified Medical Device Data Systems from a Class III product requiring premarket approval, to a Class I, 510(k) exempt product. Now the agency says that it doesn’t intend to enforce even the general controls applicable to Class I products. In a guidance document issued today, …