Regulatory and Compliance
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With new draft guidance making it clear that FDA is amenable to it, now may be the right time to take another look at adaptive design for your medical device...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 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...
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 14, 2015
Marie Thibault   The House of Representatives Energy and Commerce Subcommittee on Health is charging ahead on the proposed 21st Century Cures legislation...
May 13, 2015
Marie Thibault   FDA is showing that it takes patient input and preferences seriously, by giving the medical device industry new draft guidance on the...
May 11, 2015
Marie Thibault CDRH should have no shortage of training opportunities for its medical device reviewers, as several medical device companies have offered to...
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 07, 2015
Marie Thibault   FDA has thrown out 47 of its draft guidance documents, terming them outdated due to "new information, scientific developments, and...
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...