De Novo Classification

  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. De Novo Classification

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Section
860.200

Purpose and applicability.

Section
860.210

De Novo request format.

Section
860.220

De Novo request content.

Section
860.230

Accepting a De Novo request.

Section
860.240

Procedures for review of a De Novo request.

Section
860.250

Withdrawal of a De Novo request.

Section
860.260

Granting or declining a De Novo request.