Medical Devices Regulatory and Standards Considerations from Bench to the Marketplace
(Room 309)
15 Oct 18
8:00 AM
-
8:50 AM
Tracks:
Advanced Textiles Conference, Pre-Expo Conference: Advanced Textiles
Technological innovations in the textile industry, advanced research in electronic sensors embedded in health-monitoring fabrics, and other advances are changing the public health landscape with more personalized healthcare and rapidly emerging wearable devices. While smart fabrics can be used in wellness and health applications, medical devices will require regulatory control. Can a better understanding of regulatory considerations and use of industry standards improve the time to market? Attendees will acquire general knowledge on common pathways to market a medical device in the United States. Some examples will be used to demonstrate device classes and levels of regulatory controls.
1. Learn the definition of a medical device, an FDA-regulated product, from a general wellness product.
2. Gain an understanding that device classification defines the regulatory requirements for a device type.
3. Recognize that use of voluntary consensus standards for medical devices helps streamline the regulatory review process and reduce time to market.