jueves, 3 de mayo de 2018

The FDA Reclassifies Sharps Needle Destruction Device

Today, the U.S. Food and Drug Administration (FDA) issued a final order “General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device.” Under this final order, the FDA has reclassified the needle destruction device from a class III to a class II device and renamed the device type to sharps needle destruction device.

A sharps needle destruction device is an alternative to conventional sharps/needle disposal containers found in home and hospital settings. These devices are powered by electricity or batteries and they use different technologies such as grinding or incineration to destroy 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. The 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 (PMA), but can instead submit a less burdensome premarket notification (510(k)) before marketing this type of device.

The FDA is issuing this final order 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.”

The final order can be found by searching for docket number FDA-2017-N-6216 onwww.regulations.gov. The final order will be effective starting June 4, 2018. 

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or atdice@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health

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