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FDA Reclassifies Sharps Needle Destruction Device
Devices Regulatory Affairs
Makers of needle destruction devices will no longer have to file a premarket approval application thanks to a new final order issued by the FDA.
The order renames needle destruction devices as “sharps needle destruction devices,” and reclassifies them as Class II devices with special controls, down from Class III postamendment devices.
The move was made to reduce the regulatory burden. Instead of a premarket approval application devicemakers can now submit a less burdensome 510(k) premarket notification.
The agency clarified that devices that were not in commercial distribution before May 28, 1976 — generally classified as postamendment devices — were automatically classified as Class III.