MedDeviceGuide — IVD & Medical Device Knowledge Base
How to Verify an Ultrasound Repair or Parts Provider's ISO 13485 and QMS Claims
A desktop-verification guide to auditing ISO 13485 scope, accreditation status, IAF CertSearch records, and FDA registration claims for ultrasound service vendors.
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.
FDA Human Factors Final Guidance 2026: Three Submission Categories and What Changed
Guide to FDA's final Human Factors guidance (effective August 1, 2026), covering Categories 1-3, Decision Point D flexibilities, and eSTAR submission rules.
Australia Prescribed List: Device Reimbursement Tiers, Fees and Benefit Reform
Complete guide to the Australia Prescribed List (formerly Prostheses List), covering application tiers, HPA pathways, 2026-27 cost recovery fees, benefit reductions, and post-listing review.
FDA Medical Device User Fees FY 2027: MDUFA Rate Table and Budget Decisions
Complete guide to FDA medical device user fee rates for FY 2027 (MDUFA V), covering 510(k), De Novo, PMA, registration fees, small business waivers, and filing decisions.
FDA MRI Safety Labeling and GUDID Status: Data Analysis of 5.15M Device Records
Data analysis of 5.15 million FDA GUDID records evaluating MRI safety status distribution, ASTM F2503 labeling rules, implantable device coverage gaps, and 2023 guidance compliance.
Cold Chain & Temperature-Controlled Distribution for Medical Devices & IVDs
Guide to cold chain distribution for medical devices and IVDs under ISO 13485 clause 7.5.11, GDP frameworks, shipper qualification, and excursion disposition.
FDA Bioresearch Monitoring (BIMO) and 21 CFR Part 58 GLP Device Guide
Guide to FDA Bioresearch Monitoring (BIMO) and 21 CFR Part 58 GLP for device sponsors, covering compliance manuals, NAI/VAI/OAI, and PMA pre-approval audits.
Medicare IPPS and MS-DRGs for Medical Devices: Inpatient Payment Guide
Guide to Medicare IPPS and MS-DRGs for medical devices, covering inpatient payment calculation, NTAP add-on payments, and the FY2027 Breakthrough overhaul.
China Volume-Based Procurement (VBP) for Medical Devices: Price Cuts & Strategy
Guide to China's NHSA volume-based procurement (VBP) for medical devices: round history, price cuts, provincial alliances, and multinational strategy.
FDA TAP Pilot Program Guide: Total Product Life Cycle Advisory Strategy
Guide to FDA CDRH Total Product Life Cycle Advisory (TAP) Pilot Program, Breakthrough Device eligibility, 14-day advisor meetings, and CMS payor alignment.
Why Medical Device Clinical Trials Stop Early: 6,155 Terminated Studies Analysis
Analysis of 6,155 terminated medical device trials on ClinicalTrials.gov: leading failure causes, enrollment bottlenecks, and trial survival playbooks.
Commercial Insurance Coverage for Medical Devices: Payer Policy and Prior Auth
Guide to US commercial and private-payer coverage for medical devices — medical policy, prior authorization, ERISA self-funded plans, appeals, and the Medicare NCD/LCD benchmark.
EU MDR Article 22: Systems and Procedure Packs — Producer Obligations Guide
Complete guide to EU MDR Article 22 system and procedure pack producer obligations, the no-additional-CE-mark rule, Article 22(4) triggers, UDI, and the FDA convenience-kit comparison.
Master Protocols and Platform Trials for Medical Devices: The Adoption Gap
Analysis of master protocol, platform, basket, and umbrella trial adoption in medical devices — with ClinicalTrials.gov data showing near-zero device uptake and when the design pays off.
FDA Medical Device Development Tools (MDDT): Program & Qualified Tools Guide
Complete guide to the FDA Medical Device Development Tools (MDDT) program: 4 tool categories, 2-phase no-fee qualification process, and full matrix of all 21 qualified tools.
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.
Teleflex Global Regulatory Dossier: Arrow, UroLift, FDA Data & 2025 Sale
Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.
FDA Medical Device Master Files (MAF): Types, LOA & Sourcing Strategy (2026)
2026 guide to FDA Medical Device Master Files (MAF under 21 CFR 814.20): functional categories, LOA workflow, MAF vs DMF vs DMR, and eSTAR integration.
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.