# General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
> **Food and Drug Administration** · Final order. · Published 2018-05-04 · Effective 2018-06-04 · 83 FR 19626
## Document
- **Document number:** 2018-09434
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 19626
- **CFR reference:** 21 CFR 880
- **Publication date:** 2018-05-04
- **Effective date:** 2018-06-04
- **HHS docket:** Docket No. FDA-2017-N-6216
## Abstract

The Food and Drug Administration (FDA or the Agency) is issuing a final 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 special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device. This order reclassifies these types of devices from class III to class II and will reduce regulatory burdens on industry because 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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/05/04/2018-09434/general-hospital-and-personal-use-devices-reclassification-of-sharps-needle-destruction-device)
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