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.
The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.
The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.