Are you ready to launch your mobile medical app in the United States? Depending on the functionality of your app, you might need clearance from the US Food and Drug Administration. But with thousands of apps on the market, how do you know if yours requires FDA clearance?
Mobile medical applications are moving targets as far as the FDA is concerned. While some requirements are well-defined, the FDA still reserves the right to regulate any mobile medical device on an individual basis. As a result, medical app developers face a very difficult task when it comes to determining how FDA regulations apply to their product. In this white paper, we will address your biggest questions about mobile medical app regulations in the US market.
What you will learn in this 7-page white paper:
- What kinds of apps require FDA clearance?
- What makes a medical app a medical device?
- How do I classify my app per the FDA classification system?
- What types of apps do NOT require FDA clearance?
- What is discretionary regulatory enforcement and does it apply to my app?
- What is a Medical Device Data System (MDDS)?
We answer all of these questions and many more in this whitepaper.
About the Author: Richard Vincins, CBA, CQA, RAC (US/EU)
Richard Vincins is Vice President, Quality Assurance Consulting at Emergo. With nearly 25 years of experience in the medical device industry, Richard’s areas of expertise include ISO 13485 and US FDA QSR quality system implementation, US FDA 510(k) registration, and European CE Marking.