FDA Updates

Spurring innovation to develop safer, more effective devices is key to improving patient safety.

In April 2018, the U.S. Food and Drug Admnistriation (FDA) issued a Medical Device Safety Action Plan, in which the Agency committed to strengthen and modernize its 510(k) program.

In a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the center for devices and radiological health, an update on the 510(k) program was addressed.

The intent of this public workshop is to publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance.

As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

The U.S. Food and Drug Administration has approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication.

The Food and Drug Administration (FDA) has released a draft guidance document and is seeking comments on how real-world data (RWD) collected from outside the clinical trial process should be used when making pre- and postmarket decisions for medical devices.

“The market was ready for innovation in the surgical space from an advanced imaging perspective.”

MAQUET was granted FDA 510(k) clearance for the Volista Surgical Lighting System.

FDA allowed marketing of the first biological indicator test that gives results in two hours, Verify Cronos Self Contained Biological Indicator.

Spurring innovation to develop safer, more effective devices is key to improving patient safety.

In April 2018, the U.S. Food and Drug Admnistriation (FDA) issued a Medical Device Safety Action Plan, in which the Agency committed to strengthen and modernize its 510(k) program.

In a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the center for devices and radiological health, an update on the 510(k) program was addressed.

The intent of this public workshop is to publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance.

As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

The U.S. Food and Drug Administration has approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication.

The Food and Drug Administration (FDA) has released a draft guidance document and is seeking comments on how real-world data (RWD) collected from outside the clinical trial process should be used when making pre- and postmarket decisions for medical devices.

“The market was ready for innovation in the surgical space from an advanced imaging perspective.”

MAQUET was granted FDA 510(k) clearance for the Volista Surgical Lighting System.

FDA allowed marketing of the first biological indicator test that gives results in two hours, Verify Cronos Self Contained Biological Indicator.