U.S. FDA 510(k) Medical Device Submissions Requirements

MEDERA Consulting can provide a Free Assessment of your U.S. FDA 510(k) submissions needs.

As you may be aware, many medical devices require clearance by the U.S. FDA before they can be sold in the United States. To obtain this clearance, companies must file an application and exhibits to demonstrate that the device is substantially equivalent to a device already legally marketed in the U.S., including substantial scientific and technical information.

A 510(k) is the mechanism to clear your medical device for commercial distribution and allow the product to be marketed in the United States.

Most companies have the technical expertise to compile their scientific information for a 510(k) submission. However, many companies need assistance with the structure, format and verification that all required elements are included in their 510(k) prior to submission. MEDERA Consulting provides this assistance, including:

  • A review of your product user guide and labeling (to be submitted with your 510(k))
  • Preparation and/or verification of the structure, format and required elements of your 510(k)
  • Submission of your 510(k) to the U.S. FDA
  • Assistance with changes to an already approved 510(k)
  • Correspondence with the U.S. FDA on your behalf.

Working with MEDERA Consulting can prevent incomplete submissions and costly delays.

Contact us to find out more about our U.S. FDA 510(k) Medical Device Submissions or to receive a free copy of our white paper on marketing a Medical Device in US, click here.