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FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 01 Jul)

Small Entity Compliance Guide: Laboratory Developed Tests The U.S. Food and Drug Administration (FDA) have issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT final rule published on May 6, 2024, amends the FDA’s regulations to make…
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July 10, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Regulation (EU) 2024/1860 published on Official Journal of the European Union

On 09 July, the Regulation (EU) 2024/1860 amending the EU MDR and EU IVDR has been published in the Official Journal of the European Union (OJEU). This amends the EU MDR and EU IVDR by: Further extending the transition period for certain IVDs as long as they meet certain conditions. These devices can benefit from the following transitional period: 31…
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July 10, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 24 Jun)

Please note this is an extract of the original bulletin. Go-live for the swissdamed Actors module Since 26 May 2021, Swiss economic operators (manufacturers, importers and authorised representatives) have had to register with Swissmedic in order to obtain a unique registration number (Swiss Single Registration Number – CHRN). The Actors module of swissdamed will be available from 6 August 2024. After…
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July 3, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMembership NewsMembership News Archive

IMDRF publishes “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)”

On 25 June, the IMDRF published their updated "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." This document sets out significant revisions based on regional policy changes since the last update was published in 2019. The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical…
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June 25, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA weekly update (WC 17 Jun)

Please note this is an extract of the original bulletin. Antimicrobial intravenous-to-oral switch: criteria for prompt switch Page summary: National antimicrobial intravenous-to-oral switch (IVOS) criteria for prompt switch​ have been developed for adult and paediatric patients, categorised into 5 sections. Change made: Added decision guide for paediatrics.
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June 25, 2024
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