FDA Classifies Microbiome Sample Preservation Device as Class II

The Food and Drug Administration has issued a final order classifying a specific type of medical device into Class II. The device includes containers and reagents designed to preserve microbial DNA and RNA in clinical samples. Because it was not commercially available before 1976, federal law automatically placed it in Class III, the highest risk category. The agency has now moved it to Class II through a standard reclassification process.

Why it matters: This action is mostly administrative, but it lowers the regulatory hurdle for manufacturers who want to make or sell microbiome sample collection and stabilization kits. By moving the device out of the highest risk category, the FDA reduces the paperwork and testing requirements needed to bring these products to market. The change does not approve any specific product for sale; it only sets the rules that will apply to this category of devices going forward.

Who it affects

• Manufacturers of microbiome sample collection and stabilization kits

---

This final order was issued by the Food and Drug Administration and published in the Federal Register; check the original document for the full list of special controls and compliance dates before relying on it.

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