Recall Chances Higher For 510(k) Devices With Recalled Predicates, Studies Show
Two studies recently published in JAMA argue that a higher recall rate tied to 510(k) devices cleared based on also-recalled predicate devices help to demonstrate 510(k) safety concerns.
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A case study of the Penumbra JET 7 class I recall in JAMA has again raised concerns about shortcomings in the US FDA’s 510(k) pathway in the medical community.
News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’
This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.
Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases
The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.