510K Filing
Most commercial medical devices sold in the United States require a 501(k) submission, proving that the device is at least as safe and effective or substantially equivalent to a previous device.
Realistic Quality Solutions can help:
- Access and identify substantially equivalent 510(k) devices.
- Prepare responses to FDA questions
- Identify FDA guidance materials
- Detail special FDA requirements that might impact the review of a 501(k) filing.
- Prepare and submit 510(k) documents to the FDA.
- Coordinate communications and negotiations with the FDA.
