§860.5. Confidentiality and use of data and information submitted in connection with classification and reclassification. — Inbound Citations

(30) Data and information submitted to the Commissioner or to classification panels in connection with the classification or reclassification of devices intended for human use, in § 860.5 of this chapter.

(2) The Commissioner determines that the device intended to be introduced is a class III device and cannot be marketed without premarket approval or reclassification, in which case the Commissioner will not disclose the existence of the submission unless a petition for reclassification is submitted under section 513(f)(2) of the act and its existence can be disclosed under § 860.5(d) of this chapter; or