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# FDA Renames, Reclassifies Needle Destruction Device
- URL: https://www.fdaweb.com/fda-renames-reclassifies-needle-destruction-device/
- Published: 2018-05-03T12:00:00.000Z
- Updated: 2026-09-15T00:02:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141358

FDA has issued a final order, *General Hospital and Personal Use Devices: Reclassification of Sharps Needle Destruction Device*, reclassifying the needle destruction device from Class 3 to Class 2 and renaming the device type to “sharps needle destruction device.” An agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=82999&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=0e76b2ae92fb46e19ea2c2ab1a45275c&elqaid=3376&elqat=1&ref=fdaweb.com) says a sharps needle destruction device is an alternative to conventional sharps/needle disposal containers found in home and hospital settings.

“Based on new information,” the notice says, “FDA has found sufficient information exists to establish special controls that, together with general controls, can provide a reasonable assurance of safety and effectiveness for sharps needle destruction devices,” the notice says. “FDA also believes this final order will decrease regulatory burden on manufacturers as they will no longer be required to submit a premarket approval application but can instead submit a less burdensome premarket notification before marketing this type of device.”