A
Hi all,
Two separate yet related questions for your consideration...
1. According to the Act, what is the defintion of marketing..?
2. ..and likewise, distributing?
I am asking in regard to a recent decision by the FDA to pull non-510k devices off the shelves while requesting 510k holders in the same device group to not "market" for the next 30 days while safety and effectiveness data is reviewed. Where are these definitions referenced in the Act or Title 21?
Thanks!
Two separate yet related questions for your consideration...
1. According to the Act, what is the defintion of marketing..?
2. ..and likewise, distributing?
I am asking in regard to a recent decision by the FDA to pull non-510k devices off the shelves while requesting 510k holders in the same device group to not "market" for the next 30 days while safety and effectiveness data is reviewed. Where are these definitions referenced in the Act or Title 21?
Thanks!