Code of Federal Regulations · Section
§ 1.233 — Are There Optional Items Included In The Registration Form?
21 C.F.R. § 1.233
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Yes. FDA encourages, but does not require, you to submit items that are indicated as optional on the Form FDA 3537 that you submit.
Authorizing Statute
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General orders19 U.S.C. § 1490
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Definitions; generally21 U.S.C. § 321
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Labeling15 U.S.C. § 1333
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Regulations42 U.S.C. § 216