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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
  7. Subpart D—De Novo Classification

21 CFR Part 860 - Subpart D - De Novo Classification

  • CFR
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  1. § 860.200 Purpose and applicability.
  2. § 860.210 De Novo request format.
  3. § 860.220 De Novo request content.
  4. § 860.230 Accepting a De Novo request.
  5. § 860.240 Procedures for review of a De Novo request.
  6. § 860.250 Withdrawal of a De Novo request.
  7. § 860.260 Granting or declining a De Novo request.
Source:
86 FR 54847, Oct. 5, 2021, unless otherwise noted.

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