Policy & Legislation
28 articles
FDA Emergency Use Authorization for Medical Devices: Regulatory Pathway
FDA EUA guide for medical devices covering Section 564 authority, CBRN emergency triggers, submission criteria, EUA vs 510(k)/PMA, termination, and active EUAs.
FDA Medical Device Advertising and Promotion Compliance Guide (2026)
Guide to FDA medical device advertising and promotion compliance, including 21 CFR Part 801, OPEQ enforcement, off-label claims, social media, FTC oversight, and warning letters.
LDT Regulatory Guide: FDA 2024 Rule Vacatur, CLIA Oversight, and Next Steps
Guide to LDT regulation after FDA's 2024 rule was vacated, covering CLIA oversight, enforcement discretion, ACLA litigation, and steps laboratories should take.
Medical Device Tariffs & Trade War Impact 2026: What Manufacturers Need to Know
Understand how 2026 tariffs, EU-China trade tension, and Mexico tariff changes affect medtech supply chains, with manufacturer impacts and practical mitigation strategies.
Saudi Vision 2030 and UAE Operation 300bn Medical Device Localization Guide
Guide to how Saudi Vision 2030 and UAE Operation 300bn affect medical device localization, procurement preferences, regulatory incentives, local content rules, and Gulf market entry.
How the FTC Is Shaping Medical Device M&A in 2025-2026
How FTC enforcement is reshaping medtech M&A in 2025-2026, including Edwards/JenaValve, GTCR/Surmodics, HSR changes, and state mini-HSR laws.
Medical Device Industry News and Regulatory Updates 2026
Roundup of 2026 medical device regulatory changes, FDA actions, EU MDR/IVDR milestones, and industry trends, plus what to prepare for in 2027.
Medical Device Policy & Legislation: Key Laws Shaping the Industry in 2026
Track medical device policy in 2026, from MDUFA V and VALID Act debates to EU MDR implementation, AI regulation, and global trends affecting market access.