US FDA 510(k) Submission for Medical Devices and IVDs

Accessing the U.S. Market

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:

Key Regulatory Requirements

• Part 801 – Labeling and Instructions for Use (IFU)
• Part 807 – Establishment Registration, Device Listing, and 510(k) Premarket Notification
• Part 820 – Quality System Regulation (QSR)
• Part 830 – Unique Device Identification (UDI) and GUDID submission
• Part 803 – Medical Device Reporting (MDR)
• Part 806 – Corrections and Removals

Device Classification Pathways

Class I Devices

• Require Establishment Registration and Device Listing (unless exempt)
• Must comply with Quality Management System requirements under 21 CFR Part 820

Class II and Selected Class I / III Devices

• Require 510(k) premarket notification
• Must demonstrate substantial equivalence to a legally marketed device

Our Approach

ALTRION supports manufacturers throughout the entire FDA regulatory process, including:

• Device classification and regulatory pathway definition
• Quality Management System setup and alignment with FDA requirements
• Preparation and submission of 510(k) applications
• Establishment registration and device listing
• UDI strategy and GUDID submission
• Post-market compliance and reporting

From initial assessment to market entry and beyond, we ensure a structured, compliant, and efficient pathway into the U.S. market.