The materials required for FDA registration and certification depend on the device classification and submission type. Here’s a general overview:

1. Device Classification Information

• Classification Information: Documentation that identifies the device’s classification (Class I, II, or III) and associated regulatory requirements.

2. Premarket Submission Materials

• 510(k) Notification:
  • Device Description: Detailed description of the device, its intended use, and its operating principles.
  • Substantial Equivalence: Comparison data showing how the device is similar to a legally marketed predicate device.
  • Performance Data: Test results and performance data demonstrating the device meets required standards.
  • Labeling: Proposed labels, instructions for use, and promotional materials.
• Premarket Approval (PMA):
  • Device Description: Detailed device description including design and manufacturing processes.
  • Clinical Data: Clinical trial results and data supporting the device’s safety and effectiveness.
  • Manufacturing Information: Information about the manufacturing process and facilities.
  • Risk Analysis: Assessment of potential risks associated with the device.
  • Labeling: Comprehensive labeling including directions for use, warnings, and precautions.
• De Novo Classification:
  • Device Description: Detailed description of the new device and its intended use.
  • Safety and Effectiveness Data: Evidence supporting the device’s safety and effectiveness.
  • Regulatory Controls: Proposed regulatory controls to ensure device safety and effectiveness.
  • Labeling: Proposed labeling and instructions for use.

3. Quality Management System (QMS) Documentation

• Quality Manual: Documentation of the QMS policies and procedures.
• Design Controls: Documentation related to design and development, including risk management and design validation.
• Manufacturing Controls: Records related to manufacturing processes, process validation, and control of materials.

4. Establishment Registration Materials

• Facility Information: Details about the manufacturing and distribution facilities, including address and contact information.

5. Device Listing Materials

• Device Information: Detailed information about each device being listed, including device name, classification, and intended use.

6. Adverse Event Reporting Procedures

• Report Procedures: Documentation of procedures for reporting adverse events and device-related issues to the FDA.

7. Postmarket Surveillance Plan

• Surveillance Plan: Details on monitoring device performance postmarket, managing recalls, and addressing potential issues.

8. Inspection Preparation Materials

• Inspection Records: Documentation of compliance with regulatory requirements and internal audits.

9. Other Supporting Documents

• Supporting Data: Any additional data or documentation requested by the FDA to support the submission.

Ensure that all materials are complete, accurate, and organized according to FDA guidelines to facilitate a smooth review process.

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