Most Frequently Asked Questions

Why is this portal developed?

Due to resource allocations, it is difficult for smaller companies or non-US companies to fully define 510k requirements. This portal intends to provide direct access to companies requiring 510k services, while facilitating the exchange of information.

By leveraging your knowledge about your device and streamlining the process of data gathering, we can provide better pricing on 510k submissions.

How long have you been in business? Why should we consider your services?

We have been in business since 2000 and successfully submitted many 510k notifications since then. Please review our main website

Why do I need this regulatory report, instead of just submitting a 510k?

It is more economical, in terms of time and money, to order our regulatory report first. If you need additional time to conduct more testing, for example, you can do so at your own pace.

But if I submit the 510k first anyway, wouldn’t I gain precious time to get the clearance earlier?

FDA has recently enforced more restrictions on the 510k process, forcing the submission of a 510k prematurely to ultimately cost more time and money.

What does the regulatory report include?

The regulatory report includes:

What information should I provide?

The portal will guide you through various sections, covering the 510k requirements. Have your technical file around, and be ready to upload specific information. (Automation within the sections should facilitate your work).

For best use of our services and most efficient pricing, we highly recommend the user to be your quality/regulatory manager or design engineer.

What is the quality level of the regulatory report?

The more detailed and appropriate information you provide, the higher the quality of the regulatory report.

How soon should I expect to receive the regulatory report?

Often in less than 2 weeks.

How do you charge?

We charge a flat fee of $1,500 for the regulatory report.

In most cases, and after reducing the regulatory report fee, our 510k quote would fall between $3,500 and $8,500 (excluding DeNovo or clinical studies)

Why do you charge flat fee?

The regulatory report allows us to better evaluate the amount of effort required during the 510k process, and to provide a fair quote on the 510k.

Why do you fully refund the flat fee charge with the 510k?

510k contract requires us to fully evaluate the device anyway. It is only fair not to charge twice for the same work.

Should I just upload the technical file?

No. This portal guides you step by step to answer specific questions and attach specific files in an organized manner. If you prefer not to use this portal, please email us at to initiate a quote.

What file types can I upload?

System allows uploading gif, jpeg, pdf, mpeg, doc, docx, zip, ppt, pptx, xlsx, xls, txt, tiff, and tif.

How much idle time does the system allow to answer the questions on a single web page?

System allows for 30 minutes of idle time.

Why are you sending the auto-notification emails?

The messages are included within the application (My messages) for you to access immediately. The auto-notification emails are sent as reminders, in case you did not check your messages timely.