Policy & Legislation
44 articles
Recall vs FSCA Compared: FDA 21 CFR 806, EU MDR, Brazil & Thailand
Side-by-side legal-text comparison of medical device field actions: FDA 21 CFR Part 806, EU MDR FSCA/FSN, Brazil RDC 551/2021, and Thailand recall guidance — triggers, timelines, filing objects.
UDI & Labeling Compared: FDA 801/830, EU MDR, Mexico NOM-137 & China
Legal-text comparison of medical device UDI and labeling: FDA 21 CFR Parts 801 & 830, EU MDR Article 27/Annex VI, Mexico NOM-137-SSA1-2025, and China Order 6/2014 — carriers, databases, and language.
FDA 510(k) Fees: MDUFA V User Fee Schedule and Total Cost Breakdown
Complete guide to FDA 510(k) user fees for FY 2026 under MDUFA V, including the $26,067 standard fee, $6,517 small business fee, $11,423 establishment registration, waivers, and total project cost.
FDA Prior Knowledge Framework for Cell and Gene Therapy: Draft Guidance June 2026
FDA's June 2026 draft guidance on reusing CMC, nonclinical, and clinical prior knowledge to accelerate gene therapy development, and its interaction with the Plausible Mechanism Framework.
UK MHRA International Reliance Pathway: Draft Regulations 2026 Analysis
MHRA's draft Medical Devices Regulations 2026: International Reliance Pathway for US, Canada, and Australia approvals, IVD reclassification, PCCPs for AI software, and what manufacturers must prepare.
CMS NTAP Repeal for Breakthrough Devices: FY 2027 IPPS Impact
Guide to CMS's proposed repeal of the NTAP alternative pathway, the new RAPID coverage program, commercialization impact, and next steps for device makers.
FDA Leadership Crisis 2026: Medical Device Regulatory Impact
Analysis of FDA Commissioner Marty Makary's reported May 2026 resignation, leadership departures, workforce losses, device review timeline risks, and manufacturer planning steps.
DOJ Medical Device Fraud Enforcement 2026: FCA and Anti-Kickback Risks
Guide to DOJ medical device fraud enforcement in 2026, covering False Claims Act exposure, Anti-Kickback Statute compliance, AI-driven investigations, whistleblower risk, and executive controls.
CSRD for Medical Device Companies: Sustainability Reporting Requirements in 2026
Guide to CSRD sustainability reporting for medical device companies, covering scope, ESRS standards, double materiality, Omnibus simplification, timelines, and practical compliance steps.
Privacy by Design for Medical Devices: Connected Healthcare Guide
Implement Privacy by Design in connected medical devices, with GDPR, HIPAA, data minimization, consent, anonymization, and 2026 privacy expectations.
Malaysia Medical Device Registration Cost 2026: MAR Pricing and 3-Year Budget
Buyer-side guide to Malaysia medical device registration costs, comparing MAR hourly, annual, and flat-fee pricing models with 3-year cash flow scenarios and CAB-MDA-MAR fee structure.
Medicare NCD vs LCD for Medical Devices: Coverage Strategy Guide
Compare Medicare NCD and LCD pathways for medical devices, including evidence requirements, timelines, RAPID, Coverage with Evidence Development, MACs, and coverage strategy.
Sunshine Act Open Payments Reporting for MedTech Companies: Compliance Guide
Guide to Sunshine Act and Open Payments compliance for device manufacturers, including covered recipients, reportable payments, 2026 thresholds, CMS submissions, penalties, and audits.
Thailand Medical Device Registration Cost 2026: License Holder Pricing
Thailand medical device registration cost guide for 2026, comparing Thai License Holder pricing, flat-fee options, and 3-year cash flow by device class.
UK Medical Device Registration Cost 2026: UKRP Pricing & 3-Year Cash Flow
UK medical device registration cost guide for 2026, comparing UKRP hourly, annual, and flat-fee pricing with 3-year cash flow and MHRA fee impacts.
Medical Device Product Liability and Insurance: A Complete Guide for Manufacturers
Guide to medical device product liability and insurance, including strict liability, negligence, coverage types, EU 2024/2853 changes, recalls, and risk controls.
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.