FDA Issues Final Orders to Reclassify Blood Lancet Devices as Class II and Class III Devices and to Require PMAs for the Class III Blood Lancets

Today, the U.S. Food and Drug Administration (FDA) issued two final orders to reclassify blood lancet devices, which are intended to puncture the skin to obtain a drop of blood for diagnostic purposes, and to require premarket approval for the class III blood lancets.

This action is part of the FDA’s ongoing effort to ensure the safe and effective use of blood lancets in the home and health care settings.

Facts about the final orders:

• There are three types of blood lancets that are intended for use by a single patient. These three are reclassified from class I to class II (special controls) requiring premarket notification (510(k)).
• A fourth type of blood lancet is intended for multiple patient use. That type is reclassified from class I to class III and requires a premarket approval (PMA) application or notice of completion of a product development protocol (PDP).

The classifications will be effective November 22, 2021.

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Implementation of the Final Orders:

• Manufacturers of all multiple use blood lancets for multiple patient use, now considered class III, will need to file a premarket application (PMA) within 30 months from the effective date of the final order.
• If a blood lancet for single patient use has not been on the market before the effective date, clearance of a premarket notification (510(k)) must be completed before entering the market.
• If a blood lancet for single patient use was already on the market before the effective date without an existing 510(k) clearance, the FDA does not intend to enforce for one year compliance with the requirements in the Final Order, including submission of a 510(k) or special controls.

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.