FDA To Lower Scrutiny Of CMV Tests Used In Transplant Patients
A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.
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The agency's microbiology devices advisory panel will hold a two-day meeting next month focused on classification of transplant IVDs and potential 510(k) requirements for a test that can help detect and monitor sepsis and other bacterial infection.
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.
Products like laser pointers, gun sights and lasers used to align machinery fall under a new guidance document from the US FDA, which details the limits on how much radiation these products may emit.