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. General and Plastic Surgery Devices
  7. General Provisions

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Section
878.1

Scope.

Section
878.3

Effective dates of requirement for premarket approval.

Section
878.9

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