21 CFR Subpart B
Postmarketing Safety Reporting for Combination Products
June 25, 2020
§
4.100
What is the scope of this subpart?
§
4.101
How does the FDA define key terms and phrases in this subpart?
§
4.102
What reports must you submit to FDA for your combination product or constituent part?
§
4.103
What information must you share with other constituent part applicants for the combination product?
§
4.104
How and where must you submit postmarketing safety reports for your combination product or constituent part?
§
4.105
What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
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