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Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date

This final rule delays the effective date of amendments to the existing medical product “intended use” regulations, contained in the final rule published January 9, 2017, until further notice to allow further consideration of the substantive issues raised in the comments received regarding the amendments. The Regulaory Impact Analysis is contained in the preamble of the rule.

Federal Register: 83 FR 11639, March 16, 2018

Docket: FDA-2015-N-2002