The FDA is proposing an order that would reclassify four types of blood lancets and require all devices in these categories to undergo premarket review.
The devices would go from class I, which is exempt from premarket review, to class II or class III.
Under the proposed order, the following types of blood lancets would be reclassified as class II devices: Single use only blood lancet with sharps injury prevention features; single use only blood lancet without sharps injury prevention features and multiple use blood lancet for single patient use only.
For these devices, if the proposed order becomes final, manufacturers without a cleared premarket submission will have to submit a 510(k) and receive clearance. Additionally, they would need to comply with special controls outlined in the proposed order that mitigate the risks to health associated with the blood lancets. For devices that have prior 510(k) clearance, the FDA would accept a new 510(k) and would issue a new clearance letter, as appropriate, indicating substantial equivalence and special controls compliance.
Under the proposed order, multiple use blood lancet for multiple patient use would be reclassified as class III devices.
For these devices, if the proposed order becomes final, the order would require that manufacturers of these devices submit premarket applications (PMAs) to the FDA for approval prior to marketing their device.
The orders can be found by searching docket numbers, Docket FDA-2016-N-0400 and Docket FDA-2016-M-0035, on www.regulations.gov.