US FDA 510(k) Submission
for medical devices and IVDs
Your entry point to the US market
of medical devices.
US FDA 510(k) Submission
Accessing the U.S. market requires full compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act)and relevant 21 CFR Parts, including:
- 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
Depending on classification:
- Class I devices (unless exempt) require Establishment Registration, Device Listing, and a compliant Quality Management System aligned with 21 CFR Part 820.
- Class II and selected Class I/III devices require, in addition, 510(k) premarket clearance to demonstrate substantial equivalence to a legally marketed device.
ALTRION guides manufacturers through every stage — from classification and quality system setup to FDA submission and post-market compliance — ensuring complete regulatory readiness and smooth market entry.
What We Offer
- Regulatory strategy and classification analysis
- Predicate device research and substantial equivalence justification
- Full preparation of the 510(k) dossier (Traditional, Special, Abbreviated)
- Support for eSTAR electronic submission
- Establishment Registration and Device Listing for Class I devices
- Quality System implementation and gap assessment (21 CFR Part 820)
- UDI generation and GUDID database submission (21 CFR Part 830)
- Labeling and IFU compliance (21 CFR Part 801)
- Medical Device Reporting and Corrective Action procedures (21 CFR 803 & 806)
- Communication management with the FDA and deficiency responses
- U.S. Agent representation for foreign manufacturers
Why Choose ALTRION
- Extensive experience with FDA submissions and reviewer interactions
- Expertise in QSR alignment and risk-based classification
- Optimized documentation quality and faster time-to-market
- End-to-end compliance — from registration to post-market vigilance
Deliverables
- Complete 510(k) submission package or Device Listing record
- FDA acknowledgment, clearance letter, or registration confirmation
- Regulatory summary, QSR compliance checklist, and GUDID entry confirmation
Are you interested in the US market?
Fill out the form with your request.
We will contact you as soon as possible.
Contact form
