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U.S. Department of Health and Human Services

For Industry

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How do I know if an FDA performance standard applies to my product?

Table 1 of 21 CFR 1002.1 shows a list of products followed by a reference to any applicable standard. Mandatory radiation safety performance standards are contained in Title 21 CFR Parts 1020 through 1050. The first section of each standard defines and describes products subject to that standard.

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