Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
The National Law Review5d
FDA Issues Draft Guidance on Managing Cybersecurity Risks Affecting AI-Enabled Devices
On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...
healthday3d
Wrong Smartphone Settings Can Lead to Missed Alerts From Linked Diabetes Devices
The U.S. Food and Drug Administration is urging all patients with smartphone-compatible diabetes devices to check the ...
The National Law Review3d
CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices
Contec Medical Systems (“Contec”), a global medical device and healthcare solutions company headquartered in China, sells ...
The Taipei Times13d
‘Medical devices’ cannot be resold, the FDA says
Some products bought in pharmacies, including tampons and adhesive bandages, are listed as “medical devices” in Taiwan and ...
medtechdive2d
Judge orders FDA, health agencies to restore removed webpages
District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking ...
Endocrinology Advisor4d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
The FDA has issued a safety communication regarding the potential for missed alerts with diabetes devices due to software or hardware changes.
Healthcare Dive4d
Former FDA head Gottlieb calls for less regulation of certain AI tools
Scott Gottlieb supports a reversion to an earlier interpretation of the 21st Century Cures Act, which would exempt more types ...
JD Supra11d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Illegal vapes flood U.S. market as FDA struggles to squeeze out illicit products
Take a walk to your local smoke shop and look at the labels. The U.S. Food and Drug Administration only allows retailers to ...
US FDA identifies cybersecurity risks in certain patient monitors
The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with ...
Are smartphone diabetes devices putting lives in danger? US FDA sounds alarm
The US FDA warns users of smartphone-linked diabetes devices like CGMs and insulin pumps of potential health risks due to ...