Complizen Learn

A medical device regulatory strategy is your comprehensive plan for achieving FDA clearance or approval. It includes device classification, pathway selection (510(k), De Novo, or PMA), resource planning (team, budget, consultants), timeline mapping, testing strategy, and risk mitigation. Build it during concept phase—before design freeze or testing begins—to avoid expensive mistakes and accelerate market entry. Companies that build regulatory strategy during concept phase mak

To bring a medical device to the U.S. market: (1) Classify your device (Class I, II, or III), (2) select your regulatory pathway (510(k), De Novo, or PMA), (3) complete required testing, (4) prepare and submit your FDA application, and (5) maintain post-clearance QMS compliance. Timeline ranges from 3-6 months for 510(k) to 1-3 years for PMA. This guide provides the complete roadmap from concept to U.S. market launch, with decision frameworks at each stage to help you avoid t

The FDA’s 510(k) Third-Party Review Program (3P510k)  is a voluntary alternative pathway  allowing accredited organizations  to review certain eligible Class I and II medical devices  instead of FDA performing the full review.Third-party reviewers forward their technical recommendation to FDA, which aims to issue a final clearance decision within about 30 calendar days  of receiving the complete review package. By using the 3P510k route, you avoid paying FDA user fees , thoug

Preparing your first FDA submission involves five critical steps: classify your device accurately, determine the appropriate regulatory pathway (510(k), De Novo, or PMA), gather required technical and clinical documentation, consider engaging FDA through a Pre-Submission meeting, and submit through FDA's electronic systems with proper formatting and user fees. This guide provides practical, step-by-step preparation strategies specifically for startup founders navigating their

FDA reviews AI and machine learning medical devices using a regulatory framework designed for adaptive software that learns over time. The approach includes Predetermined Change Control Plans (PCCPs) that allow pre-approved algorithm modifications without additional submissions, Good Machine Learning Practice guidelines, and lifecycle management requirements addressing transparency and bias concerns. This guide covers FDA's AI/ML regulatory framework, submission requirements,

A Design History File (DHF) is a mandatory compilation of records documenting how a medical device was designed and developed according to FDA requirements under 21 CFR Part 820.30. The DHF demonstrates that design controls were followed throughout development and serves as primary evidence during FDA audits and regulatory submissions. This guide covers DHF requirements, contents, creation process, and compliance strategies to help you build audit-ready documentation. What Is

FDA device registration and listing is a mandatory annual process where medical device companies register their facilities and list their specific products with FDA. Registration identifies WHO makes devices, while listing identifies WHAT devices are made. Both are required before commercial distribution in the US. This guide covers requirements, deadlines, fees, and step-by-step compliance to help you avoid delays and maintain market access. What Is FDA Device Registration a

FDA device inspections follow QSIT (Quality System Inspection Technique). Set a host/scribe front room  and SME back room , stage core QMS records ( design controls, CAPA, complaints, process controls ), rehearse interviews, and track every document request. On arrival, log Form FDA 482 ; at closeout, capture the exact 483  wording and submit a written CAPA  (Corrective And Preventive Action) response within 15 business days . This guide provides the systematic approach regul

FDA compliance for medical devices isn't optional - it's the gateway to the largest medical device market. In the US, “FDA compliance” means: classify  the product (Class I/II/III), choose the correct route— 510(k) clearance , De Novo classification , PMA approval , or 510(k)-exempt —run a compliant quality system  (QSR until Feb 2, 2026 ; QMSR  afterward), apply labeling/UDI  rules, register & list  establishments/devices, and meet postmarket  duties (MDR 803, corrections/re

A combination product combines a medical device with a drug, biologic, or both as a single-entity , co-packaged , or cross-labeled  configuration (21 CFR 3.2(e) ). FDA classification depends on the Primary Mode of Action (PMOA) - whichever component provides the most therapeutic benefit determines which FDA center reviews your product and which regulations apply; if unclear, the Office of Combination Products  decides, and an RFD  yields a binding designation within 60 days  

A predicate device is a legally marketed U.S. device with the same intended use and technological characteristics that do not raise different questions of safety and effectiveness compared with your device. Find candidates in FDA’s Product Classification Database (by product code), FDA’s 510(k) database (by device name/manufacturer), and AccessGUDID (public UDI)—which often lists premarket submission numbers you can pivot on. Pick well and you streamline review; pick poorly a

Importing medical devices into the United States requires strict FDA compliance, and the stakes are massive. Medical device importers must ensure premarket compliance (510(k)/PMA), establishment registration and listing, proper CBP filing codes (DEV, LST, PM#), and ongoing MDR obligations. Foreign manufacturers need US agents while initial importers must maintain complaint files in the US. Products that don't meet requirements face detention, refusal, and destruction, often c

FDA requires medical device labeling to include manufacturer information, intended use, adequate directions, warnings, UDI (where applicable), and device-specific requirements. Labeling encompasses all written materials including labels, packaging, instructions for use, and promotional materials. Compliance requires both content accuracy and quality system controls under 21 CFR 820.120. This guide covers all FDA labeling requirements, common violations, and compliance strateg

Whether you need FDA approval, FDA clearance, or no regulatory submission at all depends on your device's risk classification and intended use. FDA approval (PMA) is required for high-risk Class III devices. FDA clearance (510(k)) is needed for most Class II devices and some Class I devices. However, most Class I devices and many Class II devices are exempt from premarket submissions but still require FDA registration and listing. This guide provides a complete decision frame

CMS New Technology Add-on Payment (NTAP) is the fastest path to Medicare reimbursement for by providing additional Medicare payments...

The EU AI Act is a risk-based regulation requiring AI medical devices to undergo dual compliance, single integrated CE: NB assesses AIA +...

EU AI Act requires separate AI system certification alongside medical device approval, with 36-month implementation timeline. FDA's PCCP...

IMDRF is the global forum harmonizing medical device regulations across major markets (FDA, MHRA, Health Canada, EU). On Jan, 2025, IMDRF...

Medical device companies expanding globally face a critical strategic decision: which regulatory pathway offers the fastest, most...

A medical device Quality Management System (QMS)  proves you can consistently design, make, and support safe, effective devices. It's...