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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i7
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 860
    PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
  5. subpart C
    Subpart C—Reclassification

Subpart C. 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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