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FDA Issues Safety Guidelines for Charging Medical Devices to Prevent Overheating

The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.

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FDA Issues Guidance on Voluntary Malfunction Summary Reporting Program for Device Manufacturers

The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program.

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Use Duodenoscopes with Innovative Designs to Enhance Safety, FDA Says

The U.S. FDA is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components.

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FDA Issues Safety Guidelines for Charging Medical Devices to Prevent Overheating

The agency recommendations emphasize using manufacturer-authorized accessories and avoiding overnight charging to reduce fire and injury risks.

U.S. FDA Labels Philips Expanded Ventilator Recall as Most Serious

Jan 27, 2022

Certain Philips ventilators that were recalled last year may lead to injuries or death, according to a new classification of the recall by the FDA.

FDA’s Health of Women Strategic Plan to Better Inform Medical Device Research, Regulation

Jan 19, 2022

The plan seeks to strengthen regulatory science and identify current and emerging issues in medical device research and regulation for women’s health.

Unpacking Averages: Likelihood of FDA Medical Device Inspections

Jan 5, 2022

The FDA’s new medical device inspections dashboard indicates that there are county level hotspots for inspection rates, but not state or region hotspots.

FDA Warns of Medical Device Cybersecurity Vulnerability

Dec 20, 2021

FDA raised awareness of a cybersecurity vulnerability in Apache’s Log4j software library, which is used in medical devices and supporting systems.

Medical Device Development Tool Gets FDA Qualification for MR Safety

Nov 24, 2021

MED Institute obtained FDA qualification of their new Medical Device Development Tool for virtual MRI safety evaluations.

Patient Deaths Called ‘Injury,’ ‘Other’ in FDA Medical Device Database: Study

Jul 30, 2021

An analysis of the U.S. FDA’s Manufacturer and User Facility Device Experience database has discovered that medical device-associated patient deaths are being mislabeled in the system—mistakes that could impede patient care.