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UVDI-360 Room Sanitizer Inactivates SARS-CoV-2 at 12 Feet Distance in 5 Minutes

UltraViolet Devices Inc. (UVDI) has announced that its UVDI-360 Room Sanitizer achieved greater than 99.99%, or 4log10, inactivation of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) in 5 minutes at a distance of 12 feet (3.65 meters).

oneSOURCE Creates Free Resource Page with Up-to-Date COVID-19 Vaccine Information

Today, oneSOURCE, an RLDatix company and leading healthcare management solution, announced a new COVID-19 vaccine resource page to assist healthcare professionals during the initial administration phases of the vaccine.

STERIS to Acquire Cantel Medical

STERIS plc and Cantel Medical Corp. announced that STERIS has signed a definitive agreement to acquire Cantel, through a U.S. subsidiary. Cantel is a global provider of infection prevention products and services primarily to endoscopy and dental Customers.

NEC Releases ‘WISE VISION Endoscopy’ in Europe and Japan

NEC Corporation has announced the development of “WISE VISION Endoscopy,” an AI diagnosis-support medical device software for colonoscopies, which is being released in Japan and is expected to soon be available in Europe.

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 on www.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 800-638-2041, 301-796-7100 or at dice@fda.hhs.gov.

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