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Endotracheal Tube, Cuffed


Ref. No.: NME000202


Plastic Blood Lancet, Twist Top, Light Blue Color. Item. No.: NME000202

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Plastic Blood Lancet, Twist Top


The Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture the skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single-use only blood lancets without an integral sharps injury prevention feature, and multiple-use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets that we believe are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple-use blood lancets for multiple patients uses from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information.


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, (see the “Paperwork Reduction Act of 1995” section of this document). See section X of the SUPPLEMENTARY INFORMATION section of this document for the proposed effective date of any final order that may publish based on this proposal.

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).