FDA outlines plans to address medical device shortage risks
The FDA is particularly concerned that supply chain issues are having an adverse impact on neonatal and paediatric patients.
FDA bans red food dye due to potential cancer risk
The U.S. Food and Drug Administration has officially banned red dye — called Red 3, or Erythrosine — from foods, dietary ...
Forbes28 天
Are The FDA’s New Regulations On Medical Devices Making A Difference?
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity ... to adapt to these new rules and regulations is good for manufacturers in several ...
aha.org12 天
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
Forbes1 年
Medical Device Security Is A Top Challenge For Healthcare CIO
Food and Drug Administration (FDA) regulations mandate that all medical device vendors tighten their security features with processes to find and mitigate vulnerabilities. The FDA mandate is a ...
JD Supra11 天
Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on ...
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry ...