Regulatory and Compliance
Jul 23, 2014
Earlier this month the Centers for Medicare and Medicaid Services released four new proposals to amend portions of the Sunshine Act. There are four proposed...
Jul 22, 2014
The medical device industry loves to beat up on FDA, but one person you won’t find lining up to take a shot at the agency is medtech inventor and...
Jul 14, 2014
Most medical device companies try hard to be good citizens and do their best to comply with FDA’s Byzantine regulations and policies. To varying degrees...
Jul 07, 2014
On June 26 FDA allowed the marketing of Argo Medical Technologies’s ReWalk, the first motorized device intended to act as an exoskeleton for people with...
Jul 07, 2014
Washington attorney Alan Kirschenbaum (Hyman, Phelps & McNamara) says drug and medical device companies should be aware of an HHS Inspector General...
Jul 07, 2014
Thirty months after its submission, FDA has denied a citizen petition by former CDRH branch chief Morris Waxler seeking withdrawal of approved PMAs for all...
Jul 03, 2014
In a new blog post, CDRH director Jeffrey Shuren takes on critics of FDA’s handling of genetic test maker 23andMe. “Our concern remains that...
Jul 03, 2014
FDA has issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps used in sunlamp products from Class I medical devices to Class II. The...
Jul 03, 2014
3-D printing can create medical devices that can save and improve lives, but regulators are holding up progress.  By Justin Coutu Ever since Garrett...
Jul 01, 2014
FDA has approved in 62 days a EuroImmun de novo petition to allow marketing of its Anti-PLA2R IFA blood test, the first test that can help determine if a...