For medical device registration in the USA, you need to provide specific documents depending on the device classification and regulatory pathway:

1. For 510(k) Premarket Notification:

• 510(k) Application Form: Completed form FDA 3514.
• Device Description: Detailed information about the device, including its design, materials, and intended use.
• Labeling: Proposed labels, instructions for use, and other user information.
• Substantial Equivalence Comparison: Evidence demonstrating that the new device is substantially equivalent to a legally marketed device.
• Performance Testing Data: Results from tests such as bench, animal, and clinical studies, as applicable.
• Manufacturing Information: Details about the manufacturing process, quality control, and the facility.
• Risk Analysis: Analysis of potential risks associated with the device and how they are mitigated.
• Sterility Information: If applicable, information about the device’s sterility and sterilization method.

2. For Premarket Approval (PMA):

• PMA Application Form: Completed form FDA 356h.
• Device Description: Comprehensive details about the device, including its design, intended use, and function.
• Clinical Data: Results from clinical trials demonstrating the device’s safety and effectiveness.
• Labeling: Proposed labels, instructions for use, and other relevant information.
• Manufacturing Information: Detailed information about the manufacturing process and controls.
• Risk Analysis: In-depth analysis of potential risks and mitigation strategies.
• Performance Testing Data: Data from preclinical and clinical tests supporting the device’s performance and safety.

3. For Establishment Registration and Device Listing:

• Form FDA 2891: For establishment registration.
• Form FDA 2892: For device listing.
• Device Listing Information: Details about each device being listed, including its intended use and classification.

4. Additional Documents:

• Financial Disclosure: For PMA applications, financial disclosures of clinical investigators are required.
• Biocompatibility Data: For devices in contact with the body, provide evidence of material safety.
• Environmental Impact Information: If applicable, include information on environmental impact and waste management.

Ensure to review the FDA guidelines specific to your device type and regulatory pathway to ensure all necessary documents are accurately prepared and submitted.

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