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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…
Ben Kemp
August 22, 2025
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For input by 29/8: ECHA RAC Talc Opinion/Classification Carcinogenic 1B

Dear members, please see below call for feedback regarding the classification of ‘Talc’ as Class 1B Carcinogen. The focus is on Medial devices. I’m not aware of any IVD devices that utilise ‘Talc’, but if your impacted please contact me via regulatory@bivda.org.uk We are writing to inform you that recently, the European Chemical Agency’s (ECHA) Risk Assessment Committee (RAC) published…
Ben Kemp
August 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 14 08 25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: IPAFFS Scheduled Update - 14 August Lumpy skin disease: import of animal by-products from France,…
Ben Kemp
August 21, 2025
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Just Released: CLSI NBS11: Guidance for Newborn Screening of Congenital Adrenal Hyperplasia

The new CLSI NBS11 - Newborn Screening for Congenital Adrenal Hyperplasia, provides laboratories with clear recommendations for using dried blood spot specimens to perform newborn screening (NBS) for congenital adrenal hyperplasia (CAH). This newly released standard covers the full testing process, including preanalytical, analytical, and postanalytical phases, as well as both short-term and long-term follow-up considerations.  
Ben Kemp
August 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA – Announcing our Route B substantial modification pilot

Although the below update is specific to drug trials it includes information of when sponsors need to make Change notifications/submissions which includes when there are changes to technical equipment used during the trial, or when there are changes to diagnostics used to monitor the trial. Join our Route B substantial modification pilot  A Route B substantial modification refers to a…
Ben Kemp
August 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

CLP: Publication of GB MCL Agency Opinions

Publication of GB mandatory classification and labelling (GB MCL) Agency Opinions The next batch of GB MCL Agency Opinions are now available for download. A GB MCL Agency Opinion formally proposes the GB MCL for chemical substances, based on the scientific and technical assessment of the scientific data in line with the GB CLP Regulation, together with an assessment of…
Ben Kemp
August 21, 2025
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