Which medical devices are FDA approved?

On Tuesday, June 22, 2021, the American Investor Desk and POLMED – Ogólnopolska Izba Gospodarcza Wyrobów Medycznych had an event entitled “Establishing your medical devices through the FDA in the USA.” We were pleased to host Rick Proctor, Managing Partner at Breakthrough Life Sciences LLC, and Jeff L. Smith, President & CEO at Braveheart Group.

Our speakers covered various topics related to the medical devices sector in the United States, which was of interest to our attendants. The event began with how the FDA classifies its medical devices (class I, II, III) to ensure our attendants understood where their products classify.

For those who do not have an actual physical product, our speakers touched on the topic of software as a medical device (SaMD) and the three criteria needed for a mobile medical app to qualify as a medical device in regard to regulation.

Next, our speakers have covered the topics of ISO certifications compared to FDA criteria, intellectual property types to consider when going to the United States, and how U.S. government contracting works when searching for procurement/acquisition activities.

Finally, the last topic was promotional practices regarding what patients want from a medical app, starting with the apps' ease of use, user experience, integration with wearables, level of interaction with patient groups, straightforward communication with healthcare professionals, and actionable information.

The material from the event’s medical devices consultants can be downloaded below:

Presentation - Establishing your medical devices through the FDA in the USA