Home » Draft Guidance on HLA Test Kits Raises Concerns of Delays, Costs
Draft Guidance on HLA Test Kits Raises Concerns of Delays, Costs
The FDA’s draft guidance on 510(k) submissions for nucleic acid-based HLA test kits has raised concerns about manufacturing delays for new test kits and increased costs for devicemakers.
Devices & Diagnostics Letter
Devices Regulatory AffairsDevices & Diagnostics Letter
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