IVD & Diagnostics

Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.

Practical guide to the May 26, 2026 IVDR Class C deadline, covering Notified Body applications, the September 2026 agreement milestone, 2028 market access, and key pitfalls.

Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.

Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.

Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.

Plan a CLIA waiver strategy for IVDs, covering complexity categories, CW content, flex and lay-user studies, Dual 510(k) + CLIA Waiver review, timelines, and deficiencies.

Guide to regulatory, privacy, and commercial risks for DTC genetic tests, including FDA oversight, FTC claim substantiation, clinical validity, GINA, state privacy laws, and risk-report claims.

Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.

Protocol-level guide to IVD analytical validation, covering LoD, LoQ, precision, interference, cross-reactivity, stability, CLSI methods, and FDA/IVDR evidence.

Regulatory strategy for NGS IVD devices, covering FDA pathways, EU IVDR classification, companion diagnostics, bioinformatics validation, and postmarket controls.

Practical guide to RUO, IUO, and IVD labeling boundaries, covering intended use, FDA guidance, diagnostic-use triggers, marketing risk, and classification decisions.

Guide to LDT regulation after FDA's 2024 rule was vacated, covering CLIA oversight, enforcement discretion, ACLA litigation, and steps laboratories should take.

Compare IVD registration requirements across MENA, including Saudi SFDA, UAE EDE, Egypt EDA, Turkey TITCK, Israel AMAR, companion diagnostics, performance evidence, and point-of-care rules.

Practical guide to IVDR Annex VIII classification rules for IVD Classes A-D, with device examples, software guidance, IVDD-to-IVDR changes, and the 2025 EU simplification proposal.

Guide to companion diagnostic regulation, including FDA approval pathways, EU IVDR requirements, therapeutic co-development, PMA and De Novo strategy, and market access evidence.

Guide to point-of-care testing regulation, including CLIA waivers, FDA pathways, EU IVDR classification, quality management, and near-patient market trends.

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.