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e-CFR data is current as of January 19, 2021

Title 21 → Chapter I → Subchapter H → Part 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

Scope.

Definitions.

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.

Subpart B—CLASSIFICATION

§860.84

Classification procedures for “preamendments devices.”

§860.90

Consultation with panels.

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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