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Joy

Joy

Frestedt Inc., USA

Title: Not a “medical device” – Guidance for low risk, general wellness devices

Biography

Biography: Joy

Abstract

FDA issued draft guidance about “low risk” “general wellness” products in January 2015 and stated the CDRH “does not intend to examine low risk general wellness products to determine whether they are devices...” This talk will review these types of products and explain the process to determine if the product is low risk and about general wellness to fit into this category.