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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 announces more frequent inspections and unannounced audits of foreign manufacturing facilities

FDA announces more frequent inspections and unannounced audits of foreign manufacturing facilities. There is also discussion on charging higher fees for foreign inspections, to help promote the move to US domestic manufacture. https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities  
Ben Kemp
May 9, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance – updates

Please find below the recently published Guidance and draft guidance documents: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | FDA Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers | FDA Global Unique Device Identification Database…
Ben Kemp
January 16, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus standards updated

Please find the updated FDA Consensus standards: Recognized Consensus Standards: Medical Devices See this list edited to remove obvious non IVD related standards, and new entries highlighted in yellow. Remember that you can check the specifics of the degree of recognition by using the links on the righthand side of the FDA web page.
Ben Kemp
January 16, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards Update

FDA added three standards to the US Consensus Standards list in September for sterility.   Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number and Date Standard Title (click for recognition information) 09/09/2024 Sterility 14-460 Complete ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part…
Ben Kemp
October 16, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance on Conducting Clinical Trials with Decentralized Elements

This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers. In…
Ben Kemp
September 25, 2024
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