by chuck_ltd | 24 Mar, 2018 | CHCUK News & Articles, Digital Health Technology, FDA Guidance
This DRAFT guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,”...
by chuck_ltd | 8 Aug, 2016 | CHCUK News & Articles, Medical Devices, News, Real Word Evidence
FDA has issued a draft guidance to clarify how they evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices....
