JD Supra8d
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 ...
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 ...
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.
JD Supra28d
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 ...
FierceBiotech25d
FDA's device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
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 ...