General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
Information
Type
Proposed Rule
Regulated products
Published
November 7, 2017
Last updated
November 7, 2017
Description
Document number 2017-24191. The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the needle destruction device, renaming the device to "sharps needle destruction device," a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)