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

5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs

August 03-05, 2015 Orlando, USA

Frestedt

Frestedt Incorporated, USA

Posters-Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

FDA issued draft guidance about â�?�?low riskâ�? â�?�?general wellnessâ�? products in January 2015 and stated the CDRH â�?�?does not intend to examine low risk general wellness products to determine whether they are devices...â�? 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.

Biography :

Email: jf@frestedt.com