FDA Issues Two Proposed Orders to Reclassify Blood Lancets

Today the FDA issued a proposed order to reclassify four types of blood lancets and require all devices in these categories to undergo premarket review. Blood lancets are a type of medical sharp used to puncture the skin to obtain a drop of blood for diagnostic purposes. In order to provide a reasonable assurance of safety and effectiveness of these devices and minimize the associated risks, the FDA is proposing to reclassify the devices 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 (510(k)) 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, the following type of blood lancets would be reclassified as class III devices:

• Multiple use blood lancet for multiple patient use

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. A second proposed order, “Effective Date of Requirement for Premarket Approval for Blood Lancets,” outlines the proposed timeframes for submission of PMAs for these devices.

You may submit comments to the dockets about both of these actions until June 1, 2016. The docket will open tomorrow, March 3, 2016.

The orders can be found by searching for the following docket numbers on www.regulations.gov.

• Proposed Reclassification – Docket FDA-2016-N-0400
• Effective Date of Requirement for Premarket Approval – Docket FDA-2016-M-0035

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health