IVD & Diagnostics

Regulatory, commercial, and privacy risk guide for direct-to-consumer (DTC) genetic testing companies — covering FDA oversight of DTC IVDs, wellness vs. medical claims boundaries, analytical and clinical validity requirements, risk report authorization, GINA and state privacy laws, FTC advertising substantiation, 23andMe bankruptcy data precedent, and practical guidance on claims that change regulatory status.

Practical regulatory guide for home-use and self-test in vitro diagnostic devices — covering FDA pathways (OTC, prescription home use, CLIA waiver), EU IVDR self-testing requirements, human factors and lay-user usability, specimen collection errors, labeling requirements, DTC vs provider-ordered models, and post-market surveillance for consumer diagnostics.

Protocol-level analytical validation guide for IVD manufacturers — covering test plan tables, acceptance criteria, sample selection, statistical methods per CLSI standards, and FDA/EU IVDR expectations for analytical performance evidence.

Comprehensive regulatory and validation strategy for next-generation sequencing (NGS) in vitro diagnostic devices — covering FDA pathways (510(k), De Novo, PMA), proposed CDx reclassification, EU IVDR classification, wet lab and bioinformatics pipeline validation, variant calling, reference databases, clinical validity, cybersecurity, and post-market obligations.

Practical labeling and intended-use boundary guide for IVD manufacturers — covering FDA RUO/IUO guidance, clinical diagnostic use triggers, enforcement actions, marketing language risk, distributor behavior, and a decision tree for regulatory classification.

Complete guide to laboratory developed test regulation in 2026 — FDA's vacated 2024 final rule, the ACLA court decision, current CLIA oversight, enforcement discretion status, and what laboratories must do now.

Complete guide to in vitro diagnostic (IVD) registration across MENA — Saudi SFDA IVD classification (A–D) and companion diagnostic guidance, UAE EDE IVD requirements and fees, Egypt EDA IVD classes with ISO 15189/CLSI performance evaluation, Turkey TITCK IVDR-aligned framework, Israel AMAR IVD declaration route, and point-of-care testing requirements.

A practical walkthrough of all 7 IVDR classification rules in Annex VIII — with real device examples, software classification guidance, the IVDD-to-IVDR shift, and the 2025 EU simplification proposal that may reclassify certain IVDs.

Complete guide to companion diagnostic device regulation — FDA CDx approval pathways, EU IVDR requirements, co-development with therapeutics, PMA/De Novo strategies, and real-world case studies from oncology to rare diseases.

Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.

Everything you need to know about IVD device regulations — FDA classification, EU IVDR classes A-D, performance evaluation, companion diagnostics, LDTs, and global regulatory requirements.

How to conduct performance evaluation under the EU IVDR — scientific validity, analytical performance, clinical performance, classification rules, and what Notified Bodies expect.