FDA are holding a ‘town hall’ event for their Real World Evidence Guidance 18th Feb. Details via the link below. Town Hall – Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance - 02/18/2026 | FDA
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February 6, 2026 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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
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February 2, 2026 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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
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January 15, 2026 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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…
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January 12, 2026 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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
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January 12, 2026 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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…
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January 12, 2026 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA
Dear members, please see below link for FDA guidance on Real World Evidence for Medical Devices. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA
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November 13, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
FDA – Guidance – How to Prepare a Pre-Request for Designation (Pre-RFD) | FDA
New guidance has been issued regarding seeking designation of devices: How to Prepare a Pre-Request for Designation (Pre-RFD) | FDA
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September 8, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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…
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September 8, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
FDA Guidance on Medical Device User Fee – Small Business Qualification and determination 2025
You can find the guidance here.
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September 8, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Guidance on the use of Predetermined Change control plans for AI enabled device software functions
FDA has issued Guidance on the use of Predetermined Change control plans for AI enabled device software functions.
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August 28, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
FDA MDUFA Small business request form updated
FDA have updated the MUDUFA Small Business request form ( Form FDA 3602N ) used to claim lower or waived user fees.
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August 28, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
FDA Guidance Updates June 2025
Please see the two updated FDA Guidance documents from June 2025: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA Unique Device Identifier Requirements for Combination Products | FDA
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August 22, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
FDA New Classifications published
Dear members, Neil Plumridge spotted the following Politico article regarding updates to FDA classifications: Devices, diagnostics and digital health CLASSIFICATION ORDER BONANZA: The FDA’s Center for Devices and Radiological Health today issued nine medical device classification orders, primarily (eight out of the nine) for diagnostic products. The issuance of these orders is the last step in formally codifying a new…
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August 4, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
IEC 61326-2-6 Ed 4.0 2025-06 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
Dear members, The FDA yesterday announced its complete recognition of the International Electrotechnical Commission’s standard IEC 61326-2-6 Edition 4.0 2025-06. The standard applies to basic safety and essential performance of in vitro diagnostic medical electrical equipment when exposed to electromagnetic disturbances. Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number…
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July 10, 2025 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
FDA Guidance Q&A – Conducting Remote Regulatory Assessments 202506
You can find the new guidance here.
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