We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Although industry overall commended the FDA for developing guidelines for next-generation sequencing technologies for infectious disease diagnostics, stakeholders questioned whether the agency’s reference-grade databases would be sufficient to detect the vast majority of pathogens in the near future. Read More
FDA guidance on risk-benefit decisionmaking in premarket device approvals should include multiple factors for determining whether a device presents low risk, the Medical Imaging & Technology Alliance said in comments on the final guidance. Read More
Russia’s regulatory agency Roszdravnadzor and Iran’s Food and Drug Administration have entered into a cooperative agreement on the regulation of drugs and medical devices. Read More
The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. Read More