The UK government plans to update its regulatory framework for medical devices by the end of this year. Source: The GMP Letter

The FDA clarified what information devicemakers should include in their 510(k) premarket submissions for peripheral vascular atherectomy devices in a new final guidance. Source: The GMP Letter

The FDA cited six facilities for a variety of GMP lapses, including lax recordkeeping. Source: The GMP Letter

Serious quality system deficiencies that were repeat violations from a 2015 inspection landed Korean devicemaker Won Industry an FDA warning letter following an inspection of its Siheung-si, South Korea facility.…

The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a device without premarket approval. Source: The GMP Letter

Rhode Island device manufacturer Unetixs Vascular drew an FDA warning letter for failing to meet design requirements for its MultiLab Series ROODRA vascular diagnostic system. Source: The GMP Letter

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…

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. Source: The GMP Letter

The FDA will hold a March 5 workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland. Source: The…

Taiwan’s legislature passed the Medical Device Management Law, separating the country’s regulation of medical devices from pharmaceutical products for the first time — and introducing new requirements for quality management…