Exactech Appoints New Chief Financial Officer

Exactech, a developer and producer of innovative implants, instrumentation and computer-assisted technologies for joint replacement surgery, has announced Kerem Bolukbasi as its new chief financial officer (CFO). Bolukbasi joins Exactech from TPG Capital where he...

Philips launches Rapid Equipment Deployment Kit to COVID-19 response

Royal Philips has introduced its Rapid Equipment Deployment Kit for ICU ramp-ups, allowing doctors, nurses, technicians and hospital staff to quickly support critical care patient monitoring capabilities during the COVID-19 pandemic. Currently successfully in use in...

Pure Processing Hires New CFO

Pure Processing LLC, developer and provider of pre-cleaning stations, technologies and accessories for health care reprocessing departments, has announced the appointment of Carrie Pasinski, an experienced finance and operations leader, as chief financial officer for...

Delay in breast cancer operations due to COVID-19 pandemic appears to be non-life-threatening for women with early-stage disease

Results of Journal of the American College of Surgeons study should reassure breast cancer patients who experienced surgical postponements due to COVID-19 pandemic A new breast cancer study brings reassuring findings for women with early-stage breast cancer who were...

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 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



Submit a Comment

Your email address will not be published. Required fields are marked *