By Zac Amos – Cyberattacks on medical devices pose uniquely dangerous threats, facilitating data loss, enabling malfunction and risking lives. However, a software bill of materials is an important requirement that reduces these issues.
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The U.S. Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2028 through 2032. The current legislative authority for MDUFA expires on Sept. 30, 2027.
By Ellie Gabel – The rapid digitization of healthcare has ushered in a new era of connectivity and efficiency, led by the rise of the Internet of Medical Things (IoMT). This vast network of connected medical devices — from infusion pumps and patient monitors to smart imaging systems — forms the digital backbone of modern hospitals and laboratories.
By Zac Amos – While zero trust can benefit health care information technology professionals, several things should be considered before implementation. Neglecting these common challenges could cause trouble later.
By Vitaly Prus – Medical wearables device development is a dynamic field. According to eMarketer, over a quarter of the US population will use smart wearables by 2025. Besides, Market Data Forecast reports the size of the US wearable medical device market will reach $8.2 billion by 2028.
By Troy Ament – The exponential growth of IoT and medical devices has increased the attack surface of these systems. Ransomware attacks continue to grow in volume and scale, with increased impact to connected medical devices, patient care/safety, and exposure to large global integrated health delivery systems.
By Jeff Shuren MD JD & William Maisel MD MPH – Since the onset of the COVID-19 pandemic, staff at the FDA’s Center for Devices and Radiological Health have worked tirelessly to manage unprecedented workload demands to help increase access to high quality, critical products that are essential to our nation’s pandemic response.
The Centers for Medicare and Medicare Services is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients.
By Jeff Shuren MD JD & William Maisel MD MPH – At the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, we are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices.