For FDA certification of medical devices, you'll need the following technical documentation and supporting documents:
- Device Description: Detailed description of the device, its intended use, and operating principles.
- Labeling: Labels, instructions for use, and promotional materials.
- Design and Manufacturing Information: Design and development process, manufacturing process, and quality control procedures.
- Clinical Data: Clinical trials or studies demonstrating the device's safety and effectiveness (if applicable).
- Preclinical Data: Laboratory or animal testing data (if applicable).
- Risk Analysis: Risk assessment and management documentation.
- Testing Data: Performance and safety test results.
- Regulatory History: Previous approvals or certifications (if any).
- 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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