Leaders in Pharmaceutical Business Intelligence (LPBI) Group

New Guidelines by FDA in the Medical Devices Space: FDA Releases Guidance On In Vitro Companion Diagnostic Devices

Reporter: Aviva Lev-Ari, PhD, RN

New Guidelines by FDA in the Medical Devices Space

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• FDA Releases Guidance On In Vitro Companion Diagnostic Devices
• FDA Releases Draft Guidance On Radiation Biodosimetry Devices, Seeks Comments
• FDA Details Labeling Requirements For MTB-Complex Testing Devices
• FDA Unveils Recommendations For Medical Device Interoperability
• FDA Releases Guidance On Use Of Foreign Trial Data In Device Approvals
• SenoRx Expands Labeling For Contura MLB And Introduces Contura Shape Select MLB
• FDA Seeks Comment On Proposed Guidelines For High-Quality Clinical Studies

SOURCE

http://www.meddeviceonline.com/doc/fda-issues-final-guidance-for-k-devices-labeled-as-sterile-0001?s