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Electronic Code of Federal Regulations

e-CFR data is current as of January 16, 2020

Title 21Chapter ISubchapter HPart 860


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES

rule

Subpart A—GENERAL

§860.1
Scope.
§860.3
Definitions.
§860.5
Confidentiality and use of data and information submitted in connection with classification and reclassification.
§860.7
Determination of safety and effectiveness.
§860.10
Implants and life-supporting or life-sustaining devices.
§860.15
Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
rule

Subpart B—CLASSIFICATION

§860.84
Classification procedures for “preamendments devices.”
§860.90
Consultation with panels.
rule

Subpart C—RECLASSIFICATION

§860.120
General.
§860.123
Reclassification petition: Content and form.
§860.125
Consultation with panels.
§860.130
General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
§860.132
Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
§860.133
Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
§860.134
Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
§860.136
Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.

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