(a) The following Hawaii medical device requirements are enforceable notwithstanding section 521 of the act, because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: Hawaii Revised Statutes, chapter 451A, §14.1, subsection (a) with respect to medical examination of a child 10 years of age or under, and subsection (c).

(b) The following Hawaii medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them exemption from preemption: Hawaii Revised Statutes, chapter 451A, §14.1, subsection (a) to the extent that it requires a written authorization by a physician and does not allow adults to waive this requirement for personal, as well as religious reasons, and subsection (b).

[50 FR 30699, July 29, 1985; 50 FR 32694, Aug. 14, 1985]