General and Plastic Surgery Devices; Reclassification of Blood Lancets

One of the basic objectives of FDA is to provide needed safety and protection for American public. FDA is issuing an order to reclassify the Blood Lancets, considering the history of recognized blood borne pathogen transmission by blood lancets. FDA believes reclassification of the Blood lancets is necessary to provide reasonable assurance of safety and effectiveness for this device.

The following blood lancets will be reclassified:

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

The above 3 categories will be reclassified from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review

FDA is also proposing to reclassify:

• Multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval).

Submit either electronic or written comments on the proposed order by June 1, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by April 4, 2016, submit electronic comments in the following way: Federal eRulemaking Portal.

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. FDA-2016-N-0400 for “General and Plastic Surgery Devices; Reclassification of Blood Lancets” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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