Reclassification

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Medical Device Classification Procedures
  7. Reclassification

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Section
860.120

General.

Section
860.123

Reclassification petition: Content and form.

Section
860.125

Consultation with panels.

Section
860.130

General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.

Section
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.

Section
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.

Section
860.134

Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.

Section
860.136

Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.