Postmarketing Safety Reporting for Combination Products

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. Regulation of Combination Products
  7. Postmarketing Safety Reporting for Combination Products

Checkout our iOS App for a better way to browser and research.

Section
4.100

What is the scope of this subpart?

Section
4.101

How does the FDA define key terms and phrases in this subpart?

Section
4.102

What reports must you submit to FDA for your combination product or constituent part?

Section
4.103

What information must you share with other constituent part applicants for the combination product?

Section
4.104

How and where must you submit postmarketing safety reports for your combination product or constituent part?

Section
4.105

What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?