Records and reports regulations for radiation emitting electronic products--FDA. Final rule.
The Food and Drug Administration (FDA) is amending its regulations regarding the requirements for recordkeeping and reporting of adverse experiences and other information relating to radiation emitting electronic products. This rule reduces recordkeeping and reporting requirements for some products, requires only abbreviated reporting for other products, and clarifies certain requirements. The timing and content of certain reports will be revised to enhance the usefulness of the information. These amendments will improve protection of the public health while reducing regulatory burdens on manufacturers, dealers, and distributors of radiation emitting electronic products.
D003132:Commerce / Q000331:legislation & jurisprudence / Q000592:standards; D003254:Consumer Advocacy; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011634:Public Health; D011835:Radiation Protection / Q000331:legislation & jurisprudence* / Q000592:standards; D011996:Records / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration