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 ...

FDA Medical Device Regulation Over the Use of AI in ... indications that certain participants have a disease state; or (ii) a classification of the severity of participants’ disease state ...

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 ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...