FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling. Interoperability of devices […]

FDA compliant HPLC qualification and performance testing

FDA compliant HPLC qualification and performance testing is an important element of chromatographic test methods. Chromatographic test methods are used in a number of clinical applications.  The most common uses of chromatographic methods are in the quantitative and qualitative analysis of raw materials, drug substances, drug products and compounds in biological fluids. HPLC or High […]