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Electronic Code of Federal Regulations

blue pill

e-CFR Data is current as of October 16, 2014

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.
rule

Subpart B—CLASSIFICATION

§860.84
Classification procedures for “old devices.”
§860.93
Classification of implants, life-supporting or life-sustaining devices.
§860.95
Exemptions from sections 510, 519, and 520(f) of the act.
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 act.
§860.132
Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.
§860.134
Procedures for “new devices” under section 513(f) of the act and reclassification of certain devices.
§860.136
Procedures for transitional products under section 520(l) of the act.


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