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Title 21 - Title 21
Part 4 - REGULATION OF COMBINATION PRODUCTS
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GENERAL - REGULATION OF COMBINATION PRODUCTS
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10 sections
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§4.1 - What is the scope of this subpart?
Title 21, Part 4
§4.100 - What is the scope of this subpart?
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§4.101 - How does the FDA define key terms and phrases in this subpart?
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§4.102 - What reports must you submit to FDA for your combination product or constituent part?
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§4.103 - What information must you share with other constituent part applicants for the combination product?
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§4.104 - How and where must you submit postmarketing safety reports for your combination product or constituent part?
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§4.105 - What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
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§4.2 - How does FDA define key terms and phrases in this subpart?
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§4.3 - What current good manufacturing practice requirements apply to my combination product?
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§4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
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