COVID-19 Bad For Smaller Companies, Good For Innovation: Experts
Medtech experts say despite the hardships many manufacturers are facing due to the coronavirus pandemic, there are opportunities depending on the kind of company.
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The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.
The US FDA’s latest report on non-regulated health and medical software finds they are not associated with any substantial increase in risks, though the agency admits there may be some underreporting.
Four years after finalizing its electromagnetic compatibility (EMC) guidance, the US agency has proposed a draft guidance that would add significantly more details in terms of what regulators want from a sponsor’s premarket application.