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The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts. Read More
The European Commission released new details on what datasets devicemakers should include in the Eudamed database for unique device identifiers under the new Medical Device Regulation and In Vitro Diagnostic Regulation. Read More
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Read More
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AdvaMed said the draft guidance was too general in parts and that the FDA should clarify that product centers have responsibility and authority for product-specific premarket decisions.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