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The UK government has introduced a bill that would update the nation’s regulatory framework for medical devices by the end of the post-Brexit transition period which ends Dec. 31, 2020. Read More
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