To obtain FDA certification for medical products in the USA, follow these steps:

1. Determine Device Classification

• Identify the classification of the medical product (Class I, II, or III) based on its risk level and intended use. This classification dictates the regulatory pathway and submission requirements.

2. Understand Regulatory Requirements

• Class I Devices: Typically require registration and listing with the FDA but may be exempt from premarket notification.
• Class II Devices: Generally require a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device.
• Class III Devices: Require a Premarket Approval (PMA) application to provide evidence of safety and effectiveness.
• De Novo Classification: For novel devices without a predicate, request a De Novo classification to establish a new regulatory category.

3. Establish a Quality Management System (QMS)

• Implement a QMS that complies with FDA’s Quality System Regulation (QSR). This includes creating and maintaining documentation related to design controls, manufacturing processes, and quality assurance.

4. Prepare Documentation

• 510(k) Notification: Prepare and submit a 510(k) with detailed information including device description, performance data, and comparisons to a predicate device.
• PMA Application: Include comprehensive clinical data, device description, manufacturing information, and risk analysis in your PMA application.
• De Novo Request: Compile and submit evidence supporting the new device’s safety and effectiveness, including proposed regulatory controls.

5. Register Your Establishment

• Register your manufacturing and distribution facilities with the FDA through the Unified Registration and Listing System (FURLS).

6. List Your Devices

• After facility registration, list each device you intend to market with the FDA.

7. Submit the Application

• Submit the premarket notification (510(k)), PMA application, or De Novo request through FDA’s electronic submission systems or as directed by FDA guidelines.

8. FDA Review

• Initial Review: The FDA will review the submission for completeness and compliance with regulations.
• Additional Information: The FDA may request additional information or clarification.
• Expert Review: For certain submissions, such as PMAs, the FDA may involve external experts for evaluation.

9. Receive FDA Decision

• 510(k) Clearance: If the device is found to be substantially equivalent, the FDA will issue a 510(k) clearance letter.
• PMA Approval: If safety and effectiveness are demonstrated, the FDA will issue a PMA approval order.
• De Novo Classification: If granted, the FDA will classify the device and set regulatory controls.

10. Ensure Compliance with Labeling Requirements

• Develop and maintain labeling that meets FDA requirements, including directions for use, warnings, and other necessary information.

11. Postmarket Surveillance

• Implement procedures for postmarket surveillance, including monitoring device performance, reporting adverse events, and managing recalls if necessary.

12. Prepare for Inspections

• Be ready for FDA inspections to ensure compliance with regulatory requirements and QMS standards.

13. Maintain Ongoing Compliance

• Continuously adhere to FDA regulations, update documentation as needed, and ensure ongoing quality and regulatory compliance.

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