15340. (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.
15340. (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.
15340. (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.
