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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 860MEDICAL DEVICE CLASSIFICATION PROCEDURES
 

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.

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.

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.

Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
Source: 43 FR 32993, July 28, 1978, unless otherwise noted.

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