FDA Reclassifies Needle Destruction Devices
Posted 03 May 2018 | By
The US Food and Drug Administration (FDA) on Thursday finalized a proposal to reclassify needle destruction devices from Class III to Class II and to rename the device type to “sharps needle destruction” device. The final order will be effective 4 June 2018.
The final order, first proposed in November 2017
, means manufacturers will no longer be required to submit a premarket approval application but can instead submit a less burdensome premarket notification (510(k)) before marketing this type of device.
in Thursday's Federal Register that the reduced burdens on manufacturers “could increase patient access to these devices and potentially reduce accidental needle sticks, while still providing reasonable assurance of safety and effectiveness.”
The agency explained how a sharps needle destruction device is an alternative to conventional sharps/needle disposal containers and is powered by electricity or batteries to grind or incinerate needles and other types of sharps (e.g., lancets).
“Based on new information, the 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,” FDA explained.
The final order was established as part of the Center for Devices and Radiological Health’s 2014-2015 strategic priority to “Strike the Right Balance Between Premarket and Postmarket Data Collection
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device