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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 860
Subpart D - Subpart D—De Novo Classification
§ 860.200 - Purpose and applicability.
§ 860.210 - De Novo request format.
§ 860.220 - De Novo request content.
§ 860.230 - Accepting a De Novo request.
§ 860.240 - Procedures for review of a De Novo request.
§ 860.250 - Withdrawal of a De Novo request.
§ 860.260 - Granting or declining a De Novo request.
authority:
21 U.S.C. 321
(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374
source:
43 FR 32993, July 28, 1978, unless otherwise noted.
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