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.


SUBMIT A REQUEST FOR INFORMATION


510K approval