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The guideline details information sponsors need to include in their initial marketing authorization applications and during their products’ lifecycle. Read More
“This situation will lead to a lack of alignment between notified bodies with respect to the conformity assessment procedure,” MedTech Europe says. Read More
AdvaMed said the draft guidance was too general in parts and that the FDA should clarify that product centers have responsibility and authority for product-specific premarket decisions. Read More
The agency cited new regulatory challenges, counterfeit or contaminated products and an increased volume of imported products as reasons for the increased fees. Read More
The FDA may start accepting real-world evidence in support of device applications, but sponsors need to identify the sources of real-world evidence they’re using in advance, the agency said. Read More