JD Supra3d
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 ...
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
Pharmabiz1mon
CDSCO seeks industry comment on updated classification list of four medical devices categories
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 ...
al.com9d
Lay’s potato chip recall elevated to FDA’s highest-risk classification
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 ...
JD Supra24d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
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 ...