On November 22, 2021, the U.S. Food and Drug Administration (FDA) issued 2 final orders on blood lancet devices.

One order reclassified certain blood lancet devices from class I (general controls), exempt from premarket notification, into class II (special controls), subject to premarket notification. The order also reclassified certain class I devices into class III (premarket approval).

The other final order requires establishments that market devices that were reclassified into class III to file a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) to FDA.

Keep reading for details about blood lancet device reclassifications, including when FDA requires you to file pre-market notifications or approvals for your devices.

Reclassifications into Class II

FDA’s final order on the reclassification of blood lancets follows a proposed order, which FDA published in the Federal Register of March 3, 2016. The final order effectively reclassifies the following blood lancet devices from class I to class II:

• Single use only blood lancets with an integral sharps injury prevention feature
• Single use only blood lancets without an integral sharps injury prevention feature
• Multiple use blood lancets for single patient use only

FDA issued the proposed order to reclassify single patient blood lancets in response to recommendations from a device classification panel that met in June 2013. FDA is reclassifying the above products to provide a “reasonable assurance of safety and effectiveness” by establishing special controls along with general controls. For these class II devices, the special controls identified in the final order are effective on November 22, 2021.

If a single patient blood lancet product has not been offered for sale before November 22, 2021, or requires a new 510(k), the manufacturer must submit pre-market notification by November 22, 2021. If the product was previously offered for sale but did not have 510(k) clearance, the manufacturer must receive clearance by November 22, 2022. FDA will consider taking enforcement action against manufacturers who market such products without pre-market notification by the specified dates.

Reclassification into Class III and PMA Requirement>

The final order reclassifies multiple use blood lancets for multiple patient use from class I to class III. The reclassification, effective November 22, 2021, makes these products subject to pre-market approval (PMA).

FDA is reclassifying these products in response to the reclassification panel’s determination that there is not sufficient data to establish special controls for multiple use blood lancets for multiple patients. The panel concluded that these lancets may potentially present unreasonable risk of illness or injury.

FDA requires manufacturers of class III multiple patient blood lancets to file a PMA on or before May 22, 2024. If an establishment fails to file a PMA for such a device, FDA will consider the product adulterated, unless the device is under an approved application for an investigational device exemption (IDE).