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The European Commission has authorized the National Standards Authority of Ireland (NSAI) as the 11th notified body under the EU’s Medical Device Regulation. Read More
The FDA clarified what information devicemakers should include in their 510(k) premarket submissions for peripheral vascular atherectomy devices in a new final guidance. Read More
FDA Commissioner Stephen Hahn said that the agency is not aware of any medical device shortages connected to the outbreak of the novel coronavirus — but the agency is aware of 63 manufacturers representing 72 facilities in China that produce essential devices that are prone to potential shortage if there is a supply disruption. Read More
The FDA issued a new policy that will allow certain laboratories to use validated COVID-19 diagnostics while the agency reviews their Emergency Use Authorization (EUA) requests. Read More
The Medical Device Authority said a refurbished device may have been stripped into component parts of sub-assemblies, checked for suitability for reuse or had components replaced that weren’t suitable for reuse. Read More
The agency listed the differences between custom-made medical devices, patient-matched medical devices, adaptable medical devices and non-adaptable mass-produced devices. Read More
Malaysia’s Medical Device Authority has clarified its definitions for refurbished medical devices and offered guidance for devicemakers submitting notifications for such products. Read More