[{"data":1,"prerenderedAt":130},["ShallowReactive",2],{"content-fda-510k-en":3},{"id":4,"title":5,"body":6,"description":121,"extension":122,"meta":123,"navigation":125,"path":126,"seo":127,"stem":128,"__hash__":129},"content\u002Ffda-510k\u002Ffda-510k.en.md","FDA Regulatory Compliance for U.S. Market Access",{"type":7,"value":8,"toc":108},"minimark",[9,14,18,23,45,48,52,56,64,68,76,78,82,85,105],[10,11,13],"h2",{"id":12},"accessing-the-us-market","Accessing the U.S. Market",[15,16,17],"p",{},"Accessing the U.S. market requires full compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and relevant sections of Title 21 of the Code of Federal Regulations (21 CFR), including:",[19,20,22],"h3",{"id":21},"key-regulatory-requirements","Key Regulatory Requirements",[24,25,26,30,33,36,39,42],"ul",{},[27,28,29],"li",{},"Part 801 – Labeling and Instructions for Use (IFU)",[27,31,32],{},"Part 807 – Establishment Registration, Device Listing, and 510(k) Premarket Notification",[27,34,35],{},"Part 820 – Quality System Regulation (QSR)",[27,37,38],{},"Part 830 – Unique Device Identification (UDI) and GUDID submission",[27,40,41],{},"Part 803 – Medical Device Reporting (MDR)",[27,43,44],{},"Part 806 – Corrections and Removals",[46,47],"hr",{},[10,49,51],{"id":50},"device-classification-pathways","Device Classification Pathways",[19,53,55],{"id":54},"class-i-devices","Class I Devices",[24,57,58,61],{},[27,59,60],{},"Require Establishment Registration and Device Listing (unless exempt)",[27,62,63],{},"Must comply with Quality Management System requirements under 21 CFR Part 820",[19,65,67],{"id":66},"class-ii-and-selected-class-i-iii-devices","Class II and Selected Class I \u002F III Devices",[24,69,70,73],{},[27,71,72],{},"Require 510(k) premarket notification",[27,74,75],{},"Must demonstrate substantial equivalence to a legally marketed device",[46,77],{},[10,79,81],{"id":80},"our-approach","Our Approach",[15,83,84],{},"ALTRION supports manufacturers throughout the entire FDA regulatory process, including:",[24,86,87,90,93,96,99,102],{},[27,88,89],{},"Device classification and regulatory pathway definition",[27,91,92],{},"Quality Management System setup and alignment with FDA requirements",[27,94,95],{},"Preparation and submission of 510(k) applications",[27,97,98],{},"Establishment registration and device listing",[27,100,101],{},"UDI strategy and GUDID submission",[27,103,104],{},"Post-market compliance and reporting",[15,106,107],{},"From initial assessment to market entry and beyond, we ensure a structured, compliant, and efficient pathway into the U.S. market.",{"title":109,"searchDepth":110,"depth":110,"links":111},"",2,[112,116,120],{"id":12,"depth":110,"text":13,"children":113},[114],{"id":21,"depth":115,"text":22},3,{"id":50,"depth":110,"text":51,"children":117},[118,119],{"id":54,"depth":115,"text":55},{"id":66,"depth":115,"text":67},{"id":80,"depth":110,"text":81},"End-to-end support for FDA compliance, 510(k) submissions, and U.S. medical device market entry.","md",{"image":124},"\u002Fimages\u002Ffda-501k.jpeg",true,"\u002Ffda-510k\u002Ffda-510k.en",{"title":5,"description":121},"fda-510k\u002Ffda-510k.en","itTlizvBospfeo50oRQMEhFIsHM1XtpCvgahFd_SWkM",1775573784294]