Category: FDA Updates

FDA Updates

MDUFA VI Process Officially Begins With FDA Public Meeting

AdvaMed leaders call for a continued focus on timely patient access and regulatory predictability as the FDA opens discussions on the next medical device user fee agreement.

FDA Updates

FDA Finalizes Medical Device Cybersecurity Premarket Guidance

The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.

FDA Updates

FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls

Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.

Clearances

FDA OKs Inogen Simeox 200 Airway Clearance Device

The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.

Recalls

Smiths Medical Recalls Endotracheal Tubes Over Ventilation Risk

Devices are being removed from use after certain sizes were found to have smaller diameters than expected, potentially limiting airflow. Eight injuries have been reported.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.