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