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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
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

ISO 15223-1 and the Authorized Representative Symbol

A significant change with broad implications ISO 15223-1 is a crucial standard for medical device manufacturers, providing symbols to convey information about devices without relying on text. This minimizes translation needs, frees up label space, and meets various regulatory requirements. On March 5, 2025, ISO 15223-1:2021/Amd 1:2025 introduced a significant change to the Authorized Representative symbol, altering the part of…
Ben Kemp
August 4, 2025
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Historic Milestones: UK and Singapore join HealthAI

Historic Milestones: UK and Singapore join HealthAI Both Governments Building Global Momentum for Responsible AI in Health We are witnessing the emergence of a new era in healthcare AI governance, one where national boundaries give way to shared responsibility and multilateral collaboration. The recent expansion of our HealthAI Global Regulatory Network (GRN) marks not just institutional growth, but a fundamental…
Ben Kemp
July 30, 2025
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Biocides: EU active substance non-approval decisions and expiry date

Biocidal products must be phased off the NI market. Following evaluation/withdrawal of support under the EU Biocidal Products Regulation (EU BPR), a decision has been taken not to approve the following active substance/product type combinations. This will affect NI: 1,2-benzisothiazol-3(2H) - one (BIT) (CAS 2634-33-5 EC 220-120-9) in product type 2 Pyrithione zinc (CAS 13463-41-7 EC 236-671-3) in product types…
Ben Kemp
July 30, 2025
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New! Ensure Excellence in Molecular Testing with CLSI MM14

As molecular methods become essential in clinical diagnostics, the need for high-quality proficiency testing has never been greater. The brand new CLSI MM14—Design of Molecular Proficiency Testing/External Quality Assessment gives you the comprehensive guidance you need to establish or evaluate PT/EQA programs with confidence.   This essential resource covers: Creating reliable, high-quality PT/EQA schemes for molecular methods Best practices for…
Ben Kemp
July 30, 2025
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China – standards update for medical devices including IVDs

NMPA China have published a list of updated Medical Device Standards including some for IVDs including: 15 - 17α-Hydroxyprogesterone Assay Kit (Labelled Immunoassay) 17 - Information provided by the manufacturer of the medical device 18 - Motor Neuron Survival Gene (SMN) Assay Kit 19 - Aldosterone Assay Kit (Chemiluminescence Immunoassay) 20 - Colorectal Cancer-relate d Gene Methylation Detection Kit (Fluorescent…
Ben Kemp
July 10, 2025
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US Privacy Laws: Is Your Business Ready for 2025’s Data Protection Shifts? | Free Whitepaper

Are you looking for a concise yet comprehensive overview of the most impactful state-level data protection laws affecting US businesses right now?   The advancement of technology has amplified the need for robust data protection, and with 144 countries already having national privacy laws, the US states are rapidly catching up.   We've developed a crucial resource to help you…
Ben Kemp
July 4, 2025
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