The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of
FDA on Quest to Standardize Mandatory MedDvc Labeling
On 4 Jan 2013 the FDA issued, in the Federal Register, a notice of Public Workshop entitled “Accessible Standardized Medical Device Labeling”. FDA indicated the focus of the workshop is to “discuss the growing need for medical device labeling to be