Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.
Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.
The FDA did not approve the use of caffeine in alcoholic drinks, and thus the drinks cannot be legally marketed.
Poachers were no longer able to compete with the quantity and quality of legally marketed wild meat.
Indexed animal drugs are technically unapproved but still legally marketed for some minor species.
A drug listed on the Index can be legally marketed for a specific use in certain minor species.
New drugs may not be legally marketed in the United States without prior approval of the FDA.
"Companies owe it to patients to ensure their drugs are legally marketed," Autor said at a news conference.
However, just because a product is not listed does not mean that it is legally marketed or safe to use.
Provision has been made so that products not produced in accordance with the legislation cannot be legally marketed and traded within the Community from 1 January 2012.