The technical documentation and supporting evidence required for FDA medical device certification applications typically include the following:

1. Device Description

• Detailed Overview: A comprehensive description of the device, including its design, technology, intended use, and components.

2. Labeling

• Proposed Labels: Labeling, including instructions for use, packaging, and any promotional materials.

3. 510(k) Summary or 510(k) Statement

• 510(k) Summary: A summary of the device’s safety and effectiveness, including a comparison to a predicate device (for 510(k) submissions).
• 510(k) Statement: A statement indicating that the summary will be provided upon request.

4. Substantial Equivalence Comparison

• Predicate Device Comparison: Demonstration of substantial equivalence to a legally marketed predicate device (for 510(k) submissions).

5. Clinical Data

• Clinical Trials: Results from clinical trials showing the device’s safety and effectiveness (for PMA submissions).

6. Non-Clinical Test Data

• Testing Reports: Data from laboratory or bench tests, including biocompatibility, electrical safety, and performance testing.

7. Manufacturing Information

• Manufacturing Details: Information on the manufacturing process, facilities, and quality control procedures.

8. Risk Analysis

• Risk Management: A comprehensive risk analysis and management plan addressing potential hazards associated with the device.

9. Declaration of Conformity

• Compliance Evidence: Evidence of compliance with relevant FDA regulations and standards.

10. FDA Fees

• Payment Proof: Proof of payment for the required application fees.

11. Additional Supporting Documents

• Environmental Assessments: If applicable, environmental impact assessments or unique device identification (UDI) information.

These documents ensure the FDA has a complete understanding of the device and its compliance with regulatory standards.

Contact Us：

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