Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

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

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.

Need assistance?