The following Rhode Island 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: Rhode Island General Laws,  Section 5-49-2.1, and  Section 2.2, to the extent that  Section 2.2 requires hearing aid dispensers to keep copies of the certificates of need.
     
    
        
            Code of Federal Regulations
        
        [45 FR 67337, Oct. 10, 1980]