Tenn. Comp. R. & Regs. 1140-09-.07 - INSPECTIONS OF MANUFACTURERS AND WHOLESALERS/DISTRIBUTORS OF MEDICAL DEVICES

(1) Between December 1 and December 31 of each calendar year, manufacturers and wholesalers/distributors of a medical device shall submit any of the documents referenced in paragraphs (1)(a)-(c), below, which shall demonstrate immediate and continuous compliance with any and all federal and state laws and regulations and shall serve in lieu of a physical, on-site inspection conducted by the Board, subject to paragraph (3), below:

(a) A Form 482 issued by the United States Food and Drug Administration ("FDA") as evidence of a facility inspection, and, if applicable, a response letter, as documented on a Form 483, from the FDA that indicates responses to the most recent inspection findings and demonstrates no further action is warranted by the manufacturer, wholesaler/distributor or FDA; or

(b) Documented evidence, such as International Organization for Standardization ("ISO") 13485 certification number, date of visit and expiration date of certificate, from a Notified Body that the firm is in good standing and their ISO 13485 certification is valid. Responses may include dates of Phase 1 and Phase 2 assessments from a Notified Body/Registrar in the certification process; or

(c) Evidence of successful Medical Device Single Audit Program certification. Alternatively, a report including corrective action plans for a Medical Device Single Audit Program certification and approval.

(2) Failure to submit documents referenced in subparagraphs 1(a)-(c), above, or submission of a self-audit which does not demonstrate immediate and continuous compliance with any and all federal and state laws and regulations may result in a request from the Board for the production of any and all corresponding documents related to any mandatory reporting or compliance requirements directed by the federal government or its agencies, the International Standards Organization or the Medical Device Single Audit Program.

(3) Notwithstanding any rule provision to the contrary, the Board retains authority to conduct any inspection or investigation of a manufacturer or wholesalers/distributors of a medical device when, in the Board's sole determination, public health, safety, and welfare necessitates such an inspection or investigation.

Notes

Tenn. Comp. R. & Regs. 1140-09-.07

New rule filed February 1, 2022; effective 5/2/2022.

Authority: T.C.A. §§ 63-10-304, 63-10-306, and 63-10-311.