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US FDA Plans Up-Classification of Blood Lancets


US regulators have proposed reclassifying three major types of medical devices used to obtain blood samples for diagnostic purposes from Class I to Class II or III.

FDA reclassification of blood lancet medical devices for 510(k) premarket notification and PMA premarket approvalThe agency’s proposed orders target three types of blood lancets: single-use lancets with sharps injury prevention features; single-use lancets without injury prevention features; and multiple-use lancets designed for single-patient use, all of which would move from Class I to Class II. A fourth type of blood lancet, multiple-use lancets for multiple patient use, would move to Class III.

The FDA’s reclassification order stems from efforts to mitigate risks such as transmission of bloodbore pathogens, local tissue infections and skin punctures.

Comments on the FDA’s proposed reclassification orders are being accepted until June 1, 2016, after which the agency plans to issue a final order requiring premarket reviews of these devices.

More information on the FDA’s medical device classification process can be found in our whitepaper and video overview.

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