Regulatory
525 articles
Data Monitoring Committees (DMC/DSMB) in Medical Device Clinical Trials
Comprehensive guide to DMC and DSMB oversight in medical device clinical trials: FDA 2006 vs 2024 guidance, chartering, stopping rules, and operator learning curve management.
Disposable Circumcision Device Supplier Qualification: CE, ISO 13485 & MOQ
A purchasing-control guide for qualifying disposable circumcision device suppliers: CE marking, ISO 13485 scope, size mix, MOQ landed cost, and sample acceptance.
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.
Medical Cyanoacrylate Tissue Adhesive Sourcing & Regulatory Guide
A technical sourcing guide for medical cyanoacrylate tissue adhesives: intended use classification, 2-octyl vs n-butyl chemistry, ISO 10993, and lot release.
NPWT Supplier Qualification: Pump–Dressing Compatibility, Alarms, QMS and Total Cost
A technical due-diligence guide for qualifying NPWT systems: pump-dressing compatibility, alarm performance, regulatory scope, and total cost of therapy.
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.
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.
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.
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.
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.
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.
How to Choose a Medical Device CRO: Selection & Due Diligence (2026)
Vendor-neutral guide to selecting a medical device CRO: ISO 14155:2026 and ICH E6(R3) compliance, RFP execution, FDA 483 due diligence, and cost models.