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 regulatory tools are for use in medical device development.
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.