Entries by Shayne Gad

December 18th 2023: Partial Recognition of ISO 10993-17 (2023) Biological Evaluation of Medical Devices-Part 17 by the FDA

ISO 10993-17 (2023) Biological Evaluation of Medical Devices-Part 17—Toxicological Risk Assessment of Medical Device Constituents, was recognized (partially) by FDA today for implementation prior to December 20, 2026.  ISO 10993-17 describes the toxicological risk assessment process for the evaluation of constituents identified in and extractables evaluation or similar chemical characterization and defines the acceptance criteria. […]

FDA Issues Final Guidance “Use of ISO 10993-1…”

FDA has issued a final guidance on Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.  The document, issued on June 16th, can be accessed through the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf There will also be a webinar on the final guidance on July 21, 2016. It will take place […]


Upcoming Courses with CfPA

Dr. Gad frequently teaches courses, through the Center for Professional Advancement (CfPA), on various broad-based topics in toxicology. Listed below are his upcoming courses, all of which are open for registration! To take advantage of our 10% Course Director Referral Discount, when you register simply use the code CD508. We look forward to seeing you! Non-Clinical Drug Safety […]