Regulatory/Legal
May 21, 2015
With new draft guidance making it clear that FDA is amenable to it, now may be the right time to take another look at adaptive design for your medical device...
May 18, 2015
The proposed 21st Century Cures Act legislation represents a rare level of cooperation between patients, industry, healthcare professionals, FDA, and...
May 15, 2015
Feedback on a plan to set up a medical device postmarket surveillance system applauds the overall idea but points out potential hurdles. Marie Thibault...
May 08, 2015
CDRH director Jeffrey Shuren tells legislators that FDA should be the regulator of next-generation sequencing tests and pledges to develop ways to provide...
May 06, 2015
A look at what’s new in two recent legislative efforts to define FDA oversight of software. Bradley Merrill Thompson MEDTECH Act The Medical Electronic...
Apr 30, 2015
CDRH claims to be losing talented employees to industry; patient advocates believe this is evidence of a too-close relationship between the center and...
Apr 22, 2015
Marie Thibault   Here at MD+DI, we love medical devices and advances in healthcare technology. Innovative medical devices have helped us live longer...
Apr 22, 2015
Medical device companies need a superior product and patent protection for their medical devices and related methods of use, but also need to consider a few...
Apr 20, 2015
Breast Implants In January 2011, FDA issued a report saying it was aware of a potential association between breast implants and anaplastic large cell lymphoma...
Apr 20, 2015
da Vinci Surgical System Robotic surgery seems to be the way of the future—every other industry is becoming automated, so why not surgery? Intuitive...