(a)Except as provided by subdivision (c), it is unlawful for any person directly, indirectly, or through another, to manufacture for sale, advertise, deliver or otherwise provide, offer for sale or lease, sell, lease, possess, or use any of the following:
(1)Any device that is not registered pursuant to this chapter, or whose registration has been canceled or suspended, except to the extent that the sale, lease, or other provision has been authorized by the director.
(2)Any registered device if any claim made for it as a part of its distribution or sale substantially differs from any claim made for it as a part of the information required in connection with its registration.
(3)Any registered device the configuration of which differs at the time of its sale, lease or other provision, o
Free access — add to your briefcase to read the full text and ask questions with AI
(a)
Except as provided by subdivision (c), it is unlawful for any person directly, indirectly, or through another, to manufacture for sale, advertise, deliver or otherwise provide, offer for sale or lease, sell, lease, possess, or use any of the following:
(1)
Any device that is not registered pursuant to this chapter, or whose registration has been canceled or suspended, except to the extent that the sale, lease, or other provision has been authorized by the director.
(2)
Any registered device if any claim made for it as a part of its distribution or sale substantially differs from any claim made for it as a part of the information required in connection with its registration.
(3)
Any registered device the configuration of which differs at the time of its sale, lease or other provision, or use from its configuration as described in the information required in connection with its registration.
(4)
Any device that is misbranded or mislabeled.
(b)
It is unlawful for any person directly, indirectly, or through another, to do any of the following:
(1)
Violate any provision of this chapter and any rules or regulations adopted by the director pursuant to this chapter.
(2)
Manufacture for sale, advertise, deliver or otherwise provide, offer for sale or lease, sell, lease, possess, or use any device, except in compliance with this chapter and regulations adopted pursuant to this chapter.
(3)
Detach, alter, deface, or destroy, in whole or in part, any device labeling.
(4)
Refuse to prepare, maintain, or submit any records or reports required by the director under this chapter or regulations adopted pursuant to this chapter for a registered device.
(5)
Use any registered device in a manner inconsistent with its registration and labeling.
(6)
Use any device that is under a valid device research permit contrary to the provisions of that permit.
(7)
Violate any order issued pursuant to this chapter.
(8)
Knowingly falsify all or part of any application for registration, application for a device research permit, any information submitted to the director pursuant to this chapter, any records required to be maintained pursuant to this chapter, or any report filed under this chapter.
(9)
Falsify all or part of any information relating to the testing of any device, including the nature of any protocol, procedure, substance, organism, or equipment used, observation made, or conclusion or opinion formed, submitted to the director, or that the person knows will be furnished to the director or will become a part of any records required to be maintained by this chapter or regulations adopted pursuant to this chapter.
(10)
Submit to the director data known to be false in support of a registration.
(c)
It is not a violation of subdivision (a) for any person to manufacture for sale, transport, or use any device pursuant to a valid research permit in effect with respect to that device and that use or possession.