The Food and Drug Administration (FDA) on Monday proposed reclassifying the needle destruction device, renamed as “sharps needle destruction device,” from a Class III device into Class II (special controls), subject to premarket notification.
FDA said it is proposing this reclassification on its own initiative based on new information. If finalized, this order will reduce regulatory burdens as these types of device makers will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome 510(k) before marketing their device.
FDA noted that what it defines as a sharps needle destruction device is a prescription device, typically electrical, “intended for home use or in professional health care facilities to destroy sharps or needles used for medical purposes by incineration or mechanical means.”
The proposed order is part of FDA’s Center for Devices and Radiological Health’s 2014-2015 strategic priority, “Strike the Right Balance Between Premarket and Postmarket Data Collection,” that retrospectively reviewed Class III devices to determine whether or not reclassification may be appropriate.
“FDA believes that the risks to health associated with sharps needle destruction devices intended for home use or in professional health care facilities to reduce the incidence of needlesticks can be mitigated with special controls and that these mitigations will provide a reasonable assurance of its safety and effectiveness,” the agency said in the Federal Register.