(a) The following Massachusetts 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:

(1) Massachusetts General Laws, Chapter 93, Section 72, to the extent that it requires a hearing test evaluation for a child under the age of 18.

(2) Massachusetts General Laws, Chapter 93, Section 74, except as provided in paragraph (6) of the Section, on the condition that, in enforcing this requirement, Massachusetts apply the definition of “used hearing aid” in §801.420(a)(6) of this chapter.

(b) The following Massachusetts medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them exemptions from preemption under section 521(b) of the act.

(1) Massachusetts General Laws, Chapter 93, Section 72, except as provided in paragraph (a) of this section.

(2) Massachusetts General Laws, Chapter 93, Section 74, to the extent that it requires that the sales receipt contain a statement that State law requires a medical examination and a hearing test evaluation before the sale of a hearing aid.

[45 FR 67326, Oct. 10, 1980]