510(k)
53 articles
FDA Product Code NAY: Surgical Robotics Clearance and Recall Trends
A deep dive into FDA product code NAY (computer-assisted surgical systems) using active registry data. Learn about 510(k) clearance trends and recall root causes.
FDA 510(k) Clearance Trends 1995-2026: Volume Stable as Traditional Submissions Take Share
Analysis of 175,149 FDA 510(k) clearances. Volume stabilized at roughly 3,200 per year after 2007, while Traditional submissions rose from 73% to 83% as Special and Abbreviated programs declined.
FDA Surgical Mesh Recalls: 171 Actions and the Polymeric-Mesh MAUDE Record
Surgical mesh analysis: 171 FDA recalls, 15 Class II enforcements, and 145,000 MAUDE reports. Bard/Davol leads recalls and reports; the POP-mesh 510(k) line was pulled to Class III in 2016.
510(k)-Exempt in 2026: How to Check the QMSR, Registration, and UDI Duties You Owe
A 510(k) exemption removes one filing, not your compliance program. How to confirm exempt status and the QMSR, registration, and UDI duties that survive.
Medical Device Accessory Classification: EU MDR and FDA Pathways
How accessories are classified separately from parent devices under EU MDR Article 2(2) and FDA 513(f)(6), with examples, MDCG 2021-24 Rev.1 updates, and FDA's 2025-2026 reclassification initiative.
Aesthetic Device Regulation: FDA 510(k) and EU MDR for Laser, RF, and Energy Devices
How energy-based aesthetic devices — laser, RF, HIFU, IPL, cryolipolysis, and EMS — are classified and cleared by FDA and EU MDR, including special controls, Annex XVI, and 2026 compliance updates.
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.
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.
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 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.
FDA 510(k) Exemptions for Class II Devices: 2026 Product Code Changes
Guide to 2026 FDA 510(k) exemption proposals and final notices for Class II devices, including affected product codes, exemption limits, criteria, and manufacturer next steps.
FDA Bone Growth Stimulator Reclassification 2026: Class III to II
Guide to FDA's 2026 reclassification of non-invasive bone growth stimulators from Class III to Class II, including special controls, 510(k) impact, CMS billing updates, and manufacturer implications.
Medical Device Clinical Trial Cost: 2026 Budget Breakdown
2026 medical device clinical trial cost guide covering per-patient costs, site fees, CRO budgets, IDE preparation, monitoring, pivotal studies, and cost-saving strategies.
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.