Policy & Legislation
48 articles
Philippines FDA Advisory 2026-1007: CPR Validity, 120-Day Clock & CMDN/CMDR
Operational guide to FDA Advisory 2026-1007: CPR validity during renewal, RA 9711 IRR 120 days, customs proof, CMDN/CMDR 90-day filing, and fee suspension.
CMS CY 2027 OPPS: Software as a Medical Service (SaMS) & Status Indicator O1
CMS-1850-P proposed SaMS policy: status indicator O1, Table 61 vs Table 62, CLFS-to-APC rate mismatch, and the August 31, 2026 comment deadline.
MHRA Ambient Voice Technology 2026: When an AI Scribe Is a Medical Device in Great Britain
MHRA and NHS England 2026 guidance on ambient voice technology (AVT): 9-example medical device qualification tree, Class I vs IIa, DCB0129, and UKCA strategy.
Medical Device Expanded Access: Emergency Use, Compassionate Use & Treatment IDE
Operational guide to US investigational device expanded access: emergency use, compassionate use IDE supplements, Treatment IDE (21 CFR 812.36), and IRB rules.
FDA Electronic Product Radiation Control (EPRC) for Medical Devices (21 CFR 1000-1050)
Guide to FDA Electronic Product Radiation Control (EPRC) under 21 CFR 1000-1050: 1002.1 matrix, Laser Notice 50/56, Form 2877, and Section 539 civil penalties.
FDA Consent Decrees of Permanent Injunction for Medical Device Manufacturers (2026)
Comprehensive guide to FDA consent decrees of permanent injunction under FD&C Act Section 302, sign-or-sue letters, CGMP remediation, executive liability, case studies, and recovery strategies.
Medicare CLFS Under PAMA: What IVD & Diagnostic Developers Must Know in 2026
Comprehensive 2026 guide to Medicare CLFS lab payment under PAMA: applicable lab rules, 3-year CDLT cycle, ADLT status, gapfilling, and CAA 2026 Section 6226 updates.
FDA Regenerative Medicine: 351/361 HCT/P Determination and RMAT Designation
A regulatory and decision framework for cell and gene therapy sponsors: determining 351 BLA vs 361 HCT/P status, qualifying for RMAT designation, and comparing expedited pathways.
Defense Production Act & Buy American for Medical Devices (2026)
A decision guide for medical device makers on U.S. domestic incentives: DPA Title III grants, Buy American Act thresholds, TAA exemptions, and tax rules.
FDA Medical Device Advisory Committees: Panel Referral & Prep (2026)
Guide to FDA Medical Devices Advisory Committee (MDAC) panel referrals under Section 515(c), voting mechanics, sponsor preparation, and TAP vs FDORA 3302.
DMEPOS Prior Authorization for Devices: Master, Required & the 2026 Exemption
A comprehensive guide to traditional Medicare DMEPOS prior authorization. Understand the Master and Required lists, the 2026 updates, and the 90% supplier exemption.
Medicare Advantage Prior Authorization for Medical Devices: Navigating the 2026 Rules
A comprehensive guide to Medicare Advantage prior authorization for medical devices. Learn about CMS-0057-F timelines, CY2026 rules, denial rates, and appeal strategies.
EU PFAS Restriction for Medical Devices: REACH Timelines and Derogations
How the EU REACH PFAS restriction affects medical device components, key transition timelines (5- and 12-year derogations), concentration limits, and substitution roadmaps.
US Medical Device Imports Teardown: Why Mexico — Not China — Is America's #1 Source
A data-driven teardown of US medical device imports using the CEPII BACI dataset, analyzing the difference between core devices and the PPE/consumables basket.
Medical Device Right to Repair: What FDA, FTC, and the Docket Record Actually Say
An evidence-based regulatory analysis of the medical device right-to-repair debate, detailing key agency findings, Regulations.gov dockets, and compliance boundaries.
Medical Device Open Payments by the Numbers: $1.20B CMS Teardown (2026)
A deep quantitative teardown of the CMS Open Payments database for medical devices. Analysis of general payments, royalty dominance, specialty concentrations, and top manufacturer footprints.
US Medical Device Import Dependence: The $14.5B Trade Deficit
A detailed analysis of US medical device import trade flows from 2013 to 2025, detailing the $14.5B core-device deficit and Section 232 tariff risks.
China Medical Device Distributor and CSO Compliance Audit Checklist
Operational audit checklist for China medtech distributors, CSOs, and clinical application specialists to meet hospital reception and anti-bribery standards.
China Medical Device Sales Representative Compliance: 2026 Guide
Will China's 2026 Medical Representative Management Measures apply to medtech field teams? Learn how device and IVD firms should prepare for upcoming rules.
Medical Device Cybersecurity Compared: FDA §524B vs EU MDR/MDCG/CRA
A comprehensive regulatory comparison of medical device cybersecurity requirements under US FDA Section 524B and the EU MDR, MDCG 2019-16, and Cyber Resilience Act (CRA).