Tennessee Code 63-10-311 – Promulgation of rules regarding oversight of facilities that manufacture, warehouse, and distribute medical devices
Current as of: 2023 | Check for updates
|
Other versions
Terms Used In Tennessee Code 63-10-311
- Board: means the Tennessee board of pharmacy. See Tennessee Code 63-10-204
- Device: means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a person duly authorized. See Tennessee Code 63-10-204
- Oversight: Committee review of the activities of a Federal agency or program.
- Representative: when applied to those who represent a decedent, includes executors and administrators, unless the context implies heirs and distributees. See Tennessee Code 1-3-105
The board shall promulgate rules regarding the board’s oversight of facilities that manufacture, warehouse, and distribute medical devices. The rulemaking process shall begin no later than September 1, 2018. The rulemaking process shall be in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, and shall include the formation of an advisory committee, in accordance with § 4-5-205, composed of medical device industry representatives and a representative of the department of economic and community development. The rules promulgated pursuant to this section shall be reviewed every three (3) years for the purpose of reviewing the advancements of new medical device technologies.