Consultants specialising in regulatory affairs




510(k) Submission (Premarket Notification)


The most common route to marketing clearance of medical devices or blood/biologic products in the United States is the 510(k) Premarket Notification process. It is the most cost effective means and is based on the claim of "substantial equivalence" of your device to that of a FDA cleared device. The first and most important aspect of this procedure is to correctly classify your product. Based on this, all requirements for a successful filing will follow: intended use, technical data, and substantial equivalence.

We will provide your company with the checklist for a complete submission. It will be our function to write the submission, based on information provided by your company and present a persuasive and convincing presentation of safety and effectiveness and substantial equivalence to the Food and Drug Administration.

In most cases, this type of submission is an inclusive fixed fee.


513(g) Submission

New medical devices are introduced into the market every year whose technology has not yet been reviewed by the Food and Drug Administration as to its safety and effectiveness. Section 513(g) of the Act (21 U.S.C. 360c(g)) provides a means for obtaining the agency's views about the classification and the regulatory requirements that may be applicable to your particular device. This provision states that within 60 days of written request, the FDA will provide the requesting party with a classification applicable to the device.