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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