10520. MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION

10520 MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION 10520.1 Submission of a premarket notification in accordance with this subsection, and a subsequent determination by the Department that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II, does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10520