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January 2, 2025
Approximately 5 minutes
US FDA Clearance Pathways: Classification, QSR, and the 510(k) / PMA Process
US FDA Clearance Pathways for Medical Devices and IVDs
The regulatory pathway to market for a medical device or In Vitro Diagnostic (IVD) product in the United States is overseen by the U.S. Food and Drug Administration (FDA). This process is mandatory for all products sold commercially in the U.S.
⚙️ Key Steps for FDA Clearance
1. Device Classification
The first step is to determine the device's classification by searching the FDA classification database. Devices are categorized based on risk:
- Class I (Low Risk): Most devices do not require premarket review.
- Class II (Medium Risk): Require 510(k) Pre-market Notification (demonstrating substantial equivalence to a legally marketed predicate device).
- Class III (High Risk): Require Premarket Approval (PMA) (demonstrating safety and effectiveness).
2. Quality Management System (QMS)
All manufacturers must establish and maintain a quality management system (QMS) compliant with the FDA Quality System Regulation (QSR) (21 CFR 820).
3. Submission (510(k) or PMA)
Based on the classification, manufacturers submit the appropriate premarket application and pay the relevant fee:
- 510(k) Submission: Required for most Class II devices. This application demonstrates that the new device is substantially equivalent to a predicate device.
- PMA Submission: Required for all Class III devices. This is the most stringent review, demanding comprehensive scientific evidence, including clinical data, to prove the device's safety and efficacy.
4. Facility Inspection
For high-risk (PMA) devices, the FDA conducts facility inspections of the manufacturer and all major suppliers to verify compliance with the QSR. The FDA then reviews the application and issues a clearance (510(k) letter) or approval (PMA letter).
5. US Agent and FURLS Registration
Once clearance or approval is obtained, the final mandatory steps for market entry are:
- US Agent Appointment: Foreign manufacturers must appoint a U.S. Agent as their local point of contact with the FDA.
- Establishment Registration & Device Listing (FURLS): Companies must annually register their establishment (facility) and list their approved devices using the FDA Unified Registration and Listing System (FURLS) and pay the relevant annual fees.
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