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U.S. Code Regulations Constitution Journal Apps
  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 D
    Subpart D—De Novo Classification

Subpart D. Subpart D—De Novo Classification

  • § 860.200 - Purpose and applicability.
  • § 860.210 - De Novo request format.
  • § 860.220 - De Novo request content.
  • § 860.230 - Accepting a De Novo request.
  • § 860.240 - Procedures for review of a De Novo request.
  • § 860.250 - Withdrawal of a De Novo request.
  • § 860.260 - Granting or declining a De Novo request.
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