Records and Reports Regulations for Radiation Emitting Electronic Products
other · Food and Drug Administration · Rule · Published 1995-09-19 · 60 FR 48374
Document
Document number
95-23130
Federal Register citation
60 FR 48374
CFR reference
21 CFR 1000
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1995-09-19
HHS docket
Docket No. 82N-0273
Abstract
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.