Mobile applications and medical devices are increasingly linked. Your app might give access to a device, turn a smartphone into a medical device, or work alongside other people's devices. Or it might not be a medical device at all.
This 60-minute webinar on FDA's enforcement strategy for mobile medical applications explains how FDA views these products, so you can adjust your development plan to stay outside FDA oversight where possible, or build in the time to prepare the information FDA needs for review.
You'll cover medical device data systems from FDA's perspective, which digital products are regulated, the regulation of mobile medical apps, FDA's recommendations for app makers, its enforcement strategy, and its future approach to the Internet of Things.
WHY SHOULD YOU ATTEND?
Knowing FDA's enforcement approach for computer-based devices and apps early helps you avoid surprises during development and plan realistic timelines. This session explains FDA's policy and its logic so you can apply it to your own product.
It suits regulatory affairs and QA managers, directors and VPs, legal counsel and consultants to FDA-regulated industries.
AREA COVERED
- Medical device data systems from FDA's perspective
- Which digital products are currently regulated
- Regulation of mobile medical applications
- FDA recommendations for makers of mobile medical apps
- FDA's enforcement strategy
- FDA's future regulation of the Internet of Things
LEARNING OBJECTIVES
- Explain FDA policy on mobile medical applications
- Understand the reasoning behind FDA's approach
- Apply FDA's policy to your own device or app
- Prepare your company for FDA requirements
WHO WILL BENEFIT?
Regulatory Affairs, Quality Assurance (Managers, Directors, Vice Presidents), Legal Counsel, Consultants to the FDA regulated industries
Knowing FDA's enforcement approach for computer-based devices and apps early helps you avoid surprises during development and plan realistic timelines. This session explains FDA's policy and its logic so you can apply it to your own product.
It suits regulatory affairs and QA managers, directors and VPs, legal counsel and consultants to FDA-regulated industries.
- Medical device data systems from FDA's perspective
- Which digital products are currently regulated
- Regulation of mobile medical applications
- FDA recommendations for makers of mobile medical apps
- FDA's enforcement strategy
- FDA's future regulation of the Internet of Things
- Explain FDA policy on mobile medical applications
- Understand the reasoning behind FDA's approach
- Apply FDA's policy to your own device or app
- Prepare your company for FDA requirements
Regulatory Affairs, Quality Assurance (Managers, Directors, Vice Presidents), Legal Counsel, Consultants to the FDA regulated industries