United States
287 articles
21 CFR Part 4: Combination Product cGMP Quality Systems for Drug-Device Manufacturers
How drug-device combination product manufacturers implement quality systems under 21 CFR Part 4 — streamlined approach, QMSR update, design controls, stability, and EU MDR Article 117.
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.
Medical Device Post-Approval Change Management: FDA, EU MDR, and Asian Markets (2026)
When device modifications require new regulatory submissions in the US, EU, Korea, Japan, and China — FDA special 510(k), PMA supplements, EU MDR significant changes, and Asian pathways.
Veterinary Medical Device Regulation: FDA CVM, EU Gaps, and Global Strategy
How veterinary medical devices are regulated under FDA CVM, EU frameworks, and key global markets. Covers classification gaps, 510(k) exemptions, off-label use, and market entry strategy.
FDA Prior Knowledge Framework for Cell and Gene Therapy: Draft Guidance June 2026
FDA's June 2026 draft guidance on reusing CMC, nonclinical, and clinical prior knowledge to accelerate gene therapy development, and its interaction with the Plausible Mechanism Framework.
FDA 510(k) Exemptions for Unclassified Devices: June 2026 Guidance Update
FDA's June 5, 2026 guidance adds five unclassified device product codes to the 510(k) exemption list. Covers all 13 codes, enforcement policy, remaining obligations, and next steps.
Medical Device Cybersecurity Is Now a Procurement Gate: 2026 Hospital Buying Data
RunSafe's 2026 Index: 56% of hospitals reject devices over cybersecurity, 35% won't buy without an SBOM, and 84% include security in RFPs. What manufacturers must do now.
FDA 510(k) Application: Submission Components and Format Requirements
Every section of an FDA 510(k) application explained — cover sheet, indications for use, device description, SE discussion, testing, labeling, software, and the eSTAR template structure.
FDA 510(k) K-Number: How to Decode It, Find It, and Use It for Regulatory Intelligence
What the 510(k) K-number means, how the format encodes the year and sequence, and how regulatory professionals use K-numbers for predicate research, competitor tracking, and submission management.
FDA 510(k) Consultants: How to Choose, Vet, and Work with a Clearance Partner
How to select, evaluate, and engage an FDA 510(k) consultant — fees by device complexity, engagement models, red flags, due diligence checklist, and when hiring one makes financial sense.
FDA Adverse Event Monitoring System (AEMS): What Replaced MAUDE for Medical Devices
FDA replaces MAUDE with AEMS — unified adverse event dashboard, migration timeline, data limitations, and reporting changes for device manufacturers.
Medical Device Software Verification vs Validation: FDA and IEC 62304 Requirements
Software verification vs validation for medical devices — FDA expectations, IEC 62304 activities, documentation, traceability, and the design control process.
FDA 510(k) Clearances: Tracking, Timelines, and Decision Data
Track FDA 510(k) clearances, understand review timelines, interpret SE/NSE decisions, use the 510(k) database, and apply clearance statistics to your 2026 regulatory strategy.
FDA 510(k) Guidance Documents: Device-Specific Requirements and Special Controls
How to find and use FDA 510(k) guidance documents, Class II special controls, device-specific submission requirements, and the CDRH FY 2026 guidance agenda to prepare stronger premarket submissions.
FDA Medical Device Registration: Step-by-Step Process from Classification to Market
Step-by-step FDA medical device registration — classification, 510(k)/De Novo/PMA pathways, establishment registration, device listing, FY 2026 fees, and post-market obligations.
Dermal Fillers vs Cosmetics vs Medicines: Hong Kong Borderline Classification After GN-00
How Hong Kong classifies injectable dermal fillers at the borderline between medical devices, cosmetics, and medicines — and why the May 2026 GN-00 update matters for your product.
eDHR for Medical Devices: QMSR, Part 11 & Digital Manufacturing (2026)
eDHR implementation guide for medical device manufacturers: QMSR requirements, 21 CFR Part 11, MES integration, ISO 13485, paper-to-digital migration, and inspection readiness.
NAMs for Medical Device Biocompatibility: FDA, EU & ISO 10993 Guide (2026)
NAMs for medical device biocompatibility: FDA roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.
RPM Device Regulatory Pathway: FDA, CMS Reimbursement & EU MDR (2026)
RPM device regulation: FDA classification, CMS 2026 CPT codes (99445, 99470), reimbursement rates, SaMD, EU MDR pathway, and commercialization strategy for connected monitoring devices.
Abbott Libre Duo CE Mark: Dual Glucose-Ketone CGM Strategy (2026)
Abbott Libre Duo CE mark analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.