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September 20, 2018
On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...
September 19, 2018
On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices. Background In July 2012, the Food and Drug...
September 13, 2018
On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian...
August 20, 2018
On Thursday, August 16th, the FDA released a list of medical device accessories that have the potential to be reclassified as class I devices. Background According to section 513 of the Food, Drug, &...
February 22, 2018
On Wednesday, February 21st, the FDA released a final rule entitled “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The new rule amends the Agency’s...