Regulatory
414 articles
Human Factors Content for FDA Medical Device Marketing Submissions
Guide to what human factors evidence to include in FDA 510(k), De Novo, or PMA submissions, including HF categories, critical tasks, use-risk analysis, validation testing, and documentation.
FDA Patient Preference Information for Medical Devices: 2026 Final Guidance
Guide to FDA Patient Preference Information for medical devices under the 2026 final guidance, including collection methods, validation, regulatory submissions, benefit-risk use, and EU alignment.
EU Breakthrough Device (BtX) Designation: MDCG 2025-9 and EMA Pilot Guide
Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.
MedTech Europe MDR/IVDR 2.0 Position Paper: Proposed Changes
Analyze MedTech Europe's May 2026 MDR/IVDR position paper, including breakthrough and orphan pathways, cybersecurity, AI, IVDR concerns, and the legislative process.
FDA One-Day AI Inspection Pilot: How Elsa Is Reshaping Medical Device Facility Oversight
Guide to FDA's May 2026 one-day AI inspection pilot using Elsa, including facility selection, screening inspection expectations, differences from standard inspections, and readiness steps.
FDA Real-Time Clinical Trials Pilot for Medical Devices
What device sponsors need to know about FDA's 2026 real-time clinical trials pilot, AI-enabled monitoring, Paradigm Health, and participation readiness.
EU Implementing Regulation 2026/977: Uniform Notified Body Requirements Under MDR and IVDR
Guide to Implementing Regulation (EU) 2026/977 for MDR and IVDR Notified Body assessments, including QMS rules, maximum timelines, clock stops, quotes, and recertification.
MDCG 2026 Updates: Classification, EMDN Codes, and Borderline Guidance
Practical guide to April 2026 MDCG updates on MDR/IVDR classification, EMDN v3/2026 codes, the Borderline Manual, and manufacturer compliance actions.
Auto-Injector Critical-Task Matrix for Human Factors Validation
Guide to auto-injector critical-task matrices for human factors validation, including URRA inputs, dose confirmation, hold time, misfire recovery, training decay, and FDA evidence expectations.
EPA Ethylene Oxide Rules for Medical Device Sterilization: 2026 Guide
Guide to the EPA's 2026 proposed EtO emissions rollback for medical device sterilization, covering the 2024 rule, compliance timelines, supply chain risk, and alternatives.
eSTAR Additional Information Response Playbook for FDA Deficiency Letters
Playbook for answering FDA Additional Information requests in eSTAR 510(k) and De Novo submissions, covering response tables, file naming, version control, section mapping, and traceability.
EUDAMED Bulk Upload Validation Error Playbook: Fix XML Rejections
Playbook for diagnosing EUDAMED bulk upload validation errors, including XSD failures, UDI mismatches, EMDN issues, certificate links, DTX codes, and pre-upload checks.
FDA AI-Enabled Device Predicate Mining for 510(k) and De Novo
Method for mining FDA AI-enabled device and 510(k) databases to identify predicates, compare technology, avoid weak arguments, and build a defensible predicate matrix.
FDA ASCA Test Report Acceptance Package for 510(k) and De Novo
Step-by-step guide to ASCA evidence packages for 510(k) and De Novo submissions, including summary test reports, declarations, lab accreditation, scope matching, and FDA questions.
FDA Third Party Review Program: 510(k) Due Diligence Checklist
Evaluate whether 3P510k review fits your device, with checks for product code eligibility, Accredited Person conflicts, eSTAR fit, timing, and risk.
GB PMSR/PSUR Dual Reporting for EU and UK Medical Devices
Structure PMSR and PSUR reports for devices sold in the EU and Great Britain, covering data periods, MHRA format, GB content, FSCA links, and retention.
Home-Use IVD Invalid Result Workflow for Consumer Diagnostics
Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.
MDUFA VI: FDA Device User Fees and 2027-2032 Reauthorization
Guide to MDUFA VI for 2027-2032, covering FDA device user fee changes, CDRH staffing, real-world evidence provisions, fee projections, and preparation steps.
NGS Bioinformatics Pipeline Change Control: Documentation and Revalidation Guide
Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.
RUO-to-IVD Conversion Firewall: Convert Research-Use Assays Without Evidence Risk
Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.