(a) The following Washington medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: Revised Code of Washington 18.35.110(2)(e) (i) and (iii) on the condition that it is enforced in addition to the applicable requirements of this chapter.

(b) The following Washington medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them an exemption from preemption under section 521(b) of the act: Revised Code of Washington 18.35.110(2)(e)(ii).

[45 FR 67337, Oct. 10, 1980]