Newsletter - March 31, 2023
FDA “New” Policy for Medical Devices with Cybersecurity Issues
Medical devices with software that connects to the internet and creates a potentially unaddressed cybersecurity vulnerability will be rejected by the FDA, starting 29 March 2023. The policy, which has been tacitly in effect since 2014 via Guidance Documents, is now being formalized into a Refuse-to-File (RTF) criteria...Read More
Why Do We Still Need Primate Toxicity Studies?
Since the beginning of the pandemic, there has been an acute shortage of monkeys for non-clinical research. Recently, due to increase in smuggling of long-tailed macaques, federal regulator started blocking imports from Cambodia, further aggravating the shortage of animals and a resulting increase in the cost and...Read More
FDA “New” Policy for Medical Devices with Cybersecurity Issues
Medical devices with software that connects to the internet and creates a potentially unaddressed cybersecurity vulnerability will be rejected by the FDA, starting 29 March 2023. The policy, which has been tacitly in effect since 2014 via Guidance Documents, is now being formalized into a Refuse-to-File (RTF) criteria...Read More
Why Do We Still Need Primate Toxicity Studies?
Since the beginning of the pandemic, there has been an acute shortage of monkeys for non-clinical research. Recently, due to increase in smuggling of long-tailed macaques, federal regulator started blocking imports from Cambodia, further aggravating the shortage of animals and a resulting increase in the cost and...Read More
