General Provisions

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Hematology and Pathology Devices
  7. General Provisions

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Section
864.1

Scope.

Section
864.3

Effective dates of requirement for premarket approval.

Section
864.9

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).