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Title 21

Displaying title 21, up to date as of 7/20/2026. Title 21 was last amended 7/20/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 860Medical Device Classification Procedures860.1 – 860.260
Subpart AGeneral860.1 – 860.15
§ 860.1Scope.
§ 860.3Definitions.
§ 860.5Confidentiality and use of data and information submitted in connection with classification and reclassification.
§ 860.7Determination of safety and effectiveness.
§ 860.10Implants and life-supporting or life-sustaining devices.
§ 860.15Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
Subpart BClassification860.84 – 860.90
§ 860.84Classification procedures for “preamendments devices.”
§ 860.90Consultation with panels.
Subpart CReclassification860.120 – 860.136
Subpart DDe Novo Classification860.200 – 860.260
§ 860.200Purpose and applicability.
§ 860.210De Novo request format.
§ 860.220De Novo request content.
§ 860.230Accepting a De Novo request.
§ 860.240Procedures for review of a De Novo request.
§ 860.250Withdrawal of a De Novo request.
§ 860.260Granting or declining a De Novo request.