2018-12201: Product Jurisdiction; Correction
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The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the Federal Register of May 15, 2018. The document was published with an error in the discussion of the preliminary economic analysis impact. This document corrects that error.
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
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