alt text Open/Close

Medical Devices

In vitro Diagnostics

FDA submissions for medical devices

You would like to launch your medical device on the US market and are facing the big challenge of obtaining approval/clearance? We will be at your side, show you the possible regulatory paths and support and advise you in your complete submission process for your medical device.

The US market is one of the largest and most important markets for medical devices. If you want to sell your devices there, you must meet the strict regulatory requirements of the FDA (Food and Drug Administration). For the approval/clearance of your medical device you have to decide between different complex regulatory pathways and strategies, depending on the classification of your device. The most used procedure is the Premarket Notification, the so-called (traditional) 510(k). This procedure is based on the substantial equivalence of the medical device to another device (predicate) on the US market.

Our experts will work closely with you to develop an approval strategy specifically tailored to your medical device and will work with you to tackle the approval process. Our independent view of your device and documents enables us to clear away potential difficulties before submission and accelerates the clearance of the medical device.

We offer:

  • Consulting on possible approval strategies
  • Product classification
  • Planning of the submission, e.g. gap-analysis regarding necessary tests, predicate search
  • File preparation and submission of
    • Pre-submissions
    • Premarket notifications / 510(k) submissions (traditional 510(k), special 510(k) & abbreviated 510(k))
    • De Novo submissions
  • Communication with the FDA during the entire process, subsequent submission of documents and, if necessary, for example submission of a Submission Issue Request (SIR)


Contact your novineon specialist.

Phone: +49 7071 98979 – 147