Regulatory and Legal
Feb 04, 2016
Marie Thibault This week, FDA released a set of human factors-related guidance documents, intended to reduce the risk of potential user mistakes and serious...
Jan 05, 2016
Marie Thibault FDA is taking a stricter approach to surgical mesh used in transvaginal repair of pelvic organ prolapse (POP), issuing two final orders...
Dec 30, 2015
Marie Thibault FDA is proposing a new policy to tell the public about emerging signals for medical devices in the postmarket setting. The agency has released...
Dec 29, 2015
Marie Thibault CDRH has mapped out its guidance priorities for the new year, publishing the "A-list" of medical device guidance documents it intends...
Dec 18, 2015
Marie Thibault     The votes are in and legislators in both the House and the Senate have passed a major tax deal that includes, among many other...
Dec 15, 2015
Marie Thibault The ReCell device from Avita Medical has earned FDA Expedited Access Pathway designation. FDA's Expedited Access Pathway (EAP) program is...
Nov 22, 2015
Gordon MacFarlane, PhD, RAC, Sandra D. White, MS, RAC, and Cynthia Nolte, PhD, RAC This year has been highly productive for FDA. Among the agency’s many...
Nov 17, 2015
Marie Thibault FDA has made no secret of its interest in regulating laboratory developed tests (LDTs) and this week, the agency bolstered its case by...
Nov 11, 2015
Nancy Crotti The Wearable Artificial Kidney allows continuous blood purification for dialysis patients.  FDA has granted its new Expedited Access Pathway...
Nov 04, 2015
Marie Thibault The controversy around the Essure permanent contraceptive device has now reached the halls of Congress. The Essure system, owned by Bayer...