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In market access and payer evaluation of new drugs, patient reported outcomes are as important for payers as are other “quantitative” measures (Biomarker levels in the blood, survival, radiological
- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.
A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.
The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class III.
The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices.
The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable predicate exists.