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FDA Updates Regulatory Affairs Newsletter Archive

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

FDA Guidance Updates

Dear Members the following FDA Final Guidance updates have been issued Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions | FDA Computer Software Assurance for Production and Quality Management System Software | FDA Clinical Decision Support Software | FDA
Ben Kemp
February 6, 2026
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus recognized standards update 20260219

Dear members please see a stripped down version of the FDA Consensus recognised standards update 19th Feb 2026. I’ve removed irrelevant subject matter entries and highlighted those in Green that maybe relevant to IVDs. Original source : Federal Register :: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065
Ben Kemp
February 2, 2026
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 ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Townhall meeting 14/01/2026

FDA Town Hall event 14th Jan for members exporting to or using FDA Conformity. The webinar will cover design and risk and some of the FAQ aspects raised by the change from the previous QSR requirements to the new QMSR ISO 13485 based requirements. Town Hall – Quality Management System Regulation: Risk and Design and Development - 01/14/2026 | FDA
Ben Kemp
January 12, 2026
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance updates

Dear Members, please note the following FDA Guidance Document updates issued since 15/12/2025: Final Guidance: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | FDA Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA Processes and Practices Applicable to Bioresearch Monitoring Inspections | FDA Clinical Decision Support Software | FDA General Wellness: Policy for…
Ben Kemp
January 12, 2026
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA fees 1st Oct 2025 to 30 Sep 2026

FDA have announced their user fess for financial year 2026. The fees will apply from 1st Oct 2025 until 30th Sep 2026. The FDA Annual Establishment Registration Fee stands at $11,423. Under the Small Business Determination (SBD) Program, small businesses able to demonstrate financial hardship according to FDA, the FDA has discretion to waive the annual establishment registration fee. This…
Ben Kemp
September 8, 2025
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