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What Technical Documentation and Supporting Documents Are Required for FDA Certification of Medical Devices?
Category：行業(yè)資訊 Date：2024-09-02 17:09:01 Author: Source:
These documents collectively help the FDA assess the safety, effectiveness, and quality of the medical device.

For FDA certification of medical devices, you'll need the following technical documentation and supporting documents:7(2).jpg

  1. Device Description: Detailed description of the device, its intended use, and operating principles.
  2. Labeling: Labels, instructions for use, and promotional materials.
  3. Design and Manufacturing Information: Design and development process, manufacturing process, and quality control procedures.
  4. Clinical Data: Clinical trials or studies demonstrating the device's safety and effectiveness (if applicable).
  5. Preclinical Data: Laboratory or animal testing data (if applicable).
  6. Risk Analysis: Risk assessment and management documentation.
  7. Testing Data: Performance and safety test results.
  8. Regulatory History: Previous approvals or certifications (if any).
  9. Compliance Statements: Evidence of compliance with relevant standards and regulations.

These documents collectively help the FDA assess the safety, effectiveness, and quality of the medical device.

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