Category: FDA Updates

FDA Updates

FDA Explains How EUA Medical Devices Can Electronically Comply with AE Reporting Requirements

The FDA has outlined the steps facilities using EUA medical devices should take to comply with AE reporting requirements electronically.

FDA Updates

FDA Announces More Class II Medical Device 510(k) Exemptions

The FDA has published a final order listing categories of Class II medical devices that are now...

FDA Updates

Stryker Launches Voluntary Field Action for Certain Lifepak 15 Monitor/Defibrillators

Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered.

Clearances

FDA Clears Boston Scientific Insertable Cardiac Monitor

Boston Scientific has received 510(k) clearance from the U.S. FDA for the LUX-Dx Insertable Cardiac Monitor System, a device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke, and syncope.

Recalls

Spike in Product Recalls Expected in COVID-19 Aftermath

While the second quarter of 2020 started with a dip in recalls, experts predict that the coronavirus pandemic will lead to an eventual spike in medical device recalls once regulators resume their traditional oversight activities.

Labeling

Ready for the UDI Enforcement Deadline?

If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.

Draft Guidances

FDA Takes Steps to Modernize 510(k) Medical Device Program

The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.