Regulatory and Compliance
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 26, 2016
FDA approved the most device approvals for first-time PMAs and HDEs in 2015 in ten years, signaling good news for the industry as a whole.  Arundhati...
Jan 19, 2016
CDRH unveils its "patient power" initiative at the same time that a third patients' group rallies against the Center's medical device safety...
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 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...
Dec 15, 2015
A recent controversy highlights the close relationship between FDA and industry, with some critics calling discussion of key legislation by the regulator and...
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 18, 2015
A number of medical devices have come under fire this year, but FDA doesn't have "imminent hazard" authority to take a device off the market....