Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
The drug regulator has sought the industry to submit their comments ... as Class A comprising low risk devices, Class B for low moderate risk devices, Class C for moderate high risk products, and ...
On January 27, the U.S. Food and Drug Administration classified the recall as “Class I,” the most severe risk level. According to the FDA, “Class I” level recalls are used in situations ...
Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation "The FDA has authorized more ...