FDA Classifies a Joint Infection Test Device as Class II

The FDA has officially placed a specific medical test for orthopedic infections into Class II of its device classification system. The device, known as the BioFire Joint Infection Panel, detects and identifies microorganism DNA and antibiotic resistance markers from patient samples. By moving it to Class II, the agency has determined that standard safety rules combined with specific performance requirements are enough to ensure the test works as intended.

Why it matters: This action is primarily administrative, but it changes how future versions of this test will be regulated. By establishing a Class II classification and setting special controls, the FDA has created a clearer path for competitors to market similar orthopedic infection tests. It also locks in specific safety and performance requirements that manufacturers must meet to avoid the stricter Class III approval process.

Who it affects

• Medical device manufacturers developing orthopedic infection diagnostic tests

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This final order was issued by the Food and Drug Administration and published in the Federal Register; readers relying on the classification details or special controls should review the original document at 21 CFR 866.3988.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document