Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

TEXT PDF860.1 Scope.
TEXT PDF860.3 Definitions.
TEXT PDF860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.
TEXT PDF860.7 Determination of safety and effectiveness.
TEXT PDF860.84 Classification procedures for ``old devices.''
TEXT PDF860.93 Classification of implants, life-supporting or life-sustaining devices.
TEXT PDF860.95 Exemptions from sections 510, 519, and 520(f) of the act.
TEXT PDF860.120 General.
TEXT PDF860.123 Reclassification petition: Content and form.
TEXT PDF860.125 Consultation with panels.
TEXT PDF860.130 General procedures under section 513(e) of the act.
TEXT PDF860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.
TEXT PDF860.134 Procedures for ``new devices'' under section 513(f) of the act and reclassification of certain devices.
TEXT PDF860.136 Procedures for transitional products under section 520(l) of the act.

--------------------------------------------------------------------- -----------

[BACK ][BACK ]