The documents required for FDA certification applications for medical devices vary based on the device classification and the submission type. Here are the key documents typically needed:
510(k) Submission:
- Cover Letter: Brief overview of the submission.
- Table of Contents: Organized outline of the submission materials.
- Device Description: Detailed description, including intended use and technological characteristics.
- Predicate Device Information: Identification of a legally marketed device for comparison.
- Labeling: Proposed labels, instructions for use, and promotional materials.
- Performance Data: Results from non-clinical testing (e.g., bench tests, biocompatibility).
- Risk Analysis: Assessment of potential risks associated with the device.
- Substantial Equivalence Discussion: Explanation of how the device is equivalent to the predicate device.
Premarket Approval (PMA):
- Cover Letter: Overview of the PMA application.
- Table of Contents: Detailed outline of the application.
- Device Description: Comprehensive details about the device and its intended use.
- Clinical Data: Results from clinical trials demonstrating safety and effectiveness.
- Manufacturing Information: Details about the manufacturing process, quality control, and facility information.
- Labeling: Proposed labels and instructions for use.
- Risk Management: Documentation of risk assessment and management plans.
Other Considerations:
- Additional documentation may be required based on specific device types, such as software documentation for software-driven devices or additional safety data for implantable devices.
Manufacturers should consult the FDA's guidance documents specific to their device type for a comprehensive list of requirements.
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