Adulterated Misbranded Device In Texas
A device may be misbranded by improper labeling or unapproved use. See TEX. HEALTH & SAFETY CODE ANN. 431.112(f)(1), (r) (Vernon Supp. 2000).
Under section 431.112(f)(1) and (2) of the FDCA, a device is misbranded unless it has adequate directions for use and has been exempted from requirements for adequate warnings against specified improper use by appropriate regulations. See id. 431.112(f)(1), (2).
The federal regulatory scheme does not contemplate a user or possessor having labeling responsibilities:
The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer.
If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. 21 C.F.R. 801.4 (1999).
If a manufacturer knows a device is to be "used for conditions, purposes, or uses other than the ones for which he offers it," the manufacturer must provide adequate labeling. Id.
An owner or operator of a device is only required to maintain labeling and advertising for a device for three years. See id. 807.31(c) (1999).