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FDA Consensus Standards

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards

Dear all, please see the latest updates to the FDA Consensus standards. Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standard Developing Organization Standard Designation Number/Date Title of Standard Transition Expiration Date 12/22/2025 Biocompatibility 2-308 Complete ASTM F1984-25 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials   12/22/2025 Biocompatibility 2-309 Complete…
Ben Kemp
January 15, 2026
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards

FDA have updated the consensus standards- as at 26/05/2025. For the degree of recognition click on the recognition information column - Recognized Consensus Standards: Medical Devices This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates. 05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing   05/26/2025…
Ben Kemp
June 9, 2025
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