The FDA registration and certification application process involves several stages:

1. Preparation and Planning

• Device Classification: Determine the device classification (Class I, II, or III) to understand the regulatory requirements.
• Identify Submission Type: Decide on the appropriate submission type (510(k), PMA, De Novo) based on device classification.

2. Documentation Preparation

• Compile Required Materials: Prepare the necessary documentation, including device description, clinical data (for PMA), performance data, and labeling.
• Quality Management System (QMS): Implement and document a QMS that complies with FDA requirements.

3. Establishment Registration and Device Listing

• Register Facilities: Register your manufacturing and distribution facilities with the FDA using the Unified Registration and Listing System (FURLS).
• List Devices: List each device with the FDA once your facility is registered.

4. Submission of Application

• 510(k) Notification: Submit a premarket notification to demonstrate substantial equivalence to a predicate device.
• PMA Application: Submit a detailed application with extensive clinical data for high-risk devices.
• De Novo Classification Request: Submit a request to create a new regulatory category for novel devices.

5. FDA Review

• Initial Review: The FDA will perform an initial review to check for completeness and compliance.
• Request for Additional Information: The FDA may request additional data or clarification.
• Review by Experts: For PMAs and some 510(k)s, the FDA may involve external experts for evaluation.

6. FDA Decision

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

7. Compliance with Labeling Requirements

• Labeling Approval: Ensure that all labeling meets FDA requirements and is included in the submission.

8. Postmarket Activities

• Postmarket Surveillance: Monitor device performance and comply with FDA requirements for adverse event reporting and device tracking.
• Handling Recalls: Manage recalls if necessary and report to the FDA.

9. FDA Inspections

• Prepare for Inspections: Be ready for FDA inspections to verify compliance with regulatory requirements and QMS standards.

10. Ongoing Compliance

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

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn