FDA The article provides an overview of the most important aspects to be considered for the impact the software could cause on the additive manufacturing process. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA The first article provides an overview of the approach applied by the FDA to applications for marketing approval for new medical devices in terms of determining their substantial equivalence to the products that are already present on the market. Table...
FDA The article describes in detail the way the medical device manufacturer may apply for exemptions from general reporting requirements, as well as the information to be included in the appropriate request. Table of Contents The Food And Drug Administration (FDA...
FDA The third in our series covering FDA guidance on additive manufactured medical devices, the present article addresses matters related to the design and manufacturing process, including those related to connections between the additive manufacturing technology used,...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device reporting requirements. The document is intended to provide additional clarifications...
