Regulatory and Legal
Jun 29, 2015
Marie Thibault   If you thought the definition of a "surgical gown" was obvious, think again. FDA has set out its policy on what is and is not a...
Jun 25, 2015
Marie Thibault As part of its unique device identifier rule, FDA has published draft guidance, "Unique Device Identification: Direct Marking of Devices,...
Jun 24, 2015
Marie Thibault FDA has published draft guidance to give industry a better idea of what the agency looks at when deciding whether to approve an Investigational...
Jun 12, 2015
Marie Thibault One of the patent reform bills introduced in this Congressional session—the Innovation Act (H.R. 9) is set to advance to the House floor...
Jun 11, 2015
Marie Thibault   Various stakeholders have banded together to encourage legislators to push for the addition of implantable medical device unique device...
Jun 09, 2015
Marie Thibault The clock is ticking on one of FDA's key initiatives to get groundbreaking medical devices to needy patients quickly. Involving both FDA and...
Jun 02, 2015
Marie Thibault Last week, the China Food and Drug Administration (CFDA) announced a major step up in registration fees for drugs and devices. According to a...
May 29, 2015
Marie Thibault Laparoscopic power morcellators continue to be in the spotlight—and that scrutinizing light may be getting harsher. The Wall Street...
May 28, 2015
Marie Thibault Earlier this month, a Delaware federal court maintained an October 2014 jury verdict that awarded Masimo Corp. $467 million against Philips...
May 20, 2015
Marie Thibault FDA has tried to tackle the dilemma of off-label use of medical devices in children by giving industry guidance on extrapolating adult clinical...