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The FDA released final guidance on 510(k) premarket submissions for peripheral vascular atherectomy devices, outlining the information devicemakers should include in their submissions. Read More
The FDA has released new details of its pilot accreditation scheme for medical device conformity assessments that it expects to launch later this year. Read More
Former FDA Commissioner Scott Gottlieb warned a Senate committee of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of components. Read More
A manufacturer that uses an ASCA-accredited testing lab can include a declaration of conformity as part of a premarket submission to the FDA. Read More
The agency amended its recommendation to identify device measurement tolerances when comparing substantial equivalence to a reference product. Read More
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. Read More
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 systems. Read More