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

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

U.S. FDA 510(k) Medical Device Submissions Can Be Complicated

Registrar Corp's team of Regulatory Advisors can provide a Free Assessment of your U.S. FDA 510(k) submissions needs. Simply click below to provide information about your device.

Learn how FDA's 510(k) submissions requirements apply to your medical device >>


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. Registrar Corp's 510(k) Administrative review provides this assistance, including:
  • A review of your product user guide and labeling (to be submitted with your 510(k))
  • Verification of the structure, format and required elements of your 510(k)
  • Submission of your 510(k) to the U.S. FDA
  • Facilitation of the U.S. FDA government fee payment
  • Correspondence with the U.S. FDA on your behalf.
Registrar Corp's 510(k) Administrative Review and Submission Service can prevent incomplete submissions and costly delays. To learn if this service would be helpful for your particular submission, simply click on the link below:

Learn how FDA's 510(k) submissions requirements apply to your medical device >>



 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.






Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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