(a) The following Maine 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: Maine Revised Statutes Annotated, Title 32, section 1658-C, on the condition that, in enforcing this requirement, Maine apply the definition of “used hearing aid” in §801.420(a)(6) of this chapter.

(b) The following Maine medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Maine Revised Statutes Annotated, Title 32, section 1658-D and the last sentence of section 1658-E.

[45 FR 67336, Oct. 10, 1980]