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  2. U.S. Code of Federal Regula...
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  4. Title 21-Food and Drugs
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  6. CHAPTER I—FOOD AND DRUG ADM...
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  8. PART 4—REGULATION OF COMBINATION PRODUCTS


PART 4—REGULATION OF COMBINATION PRODUCTS


  • § 4.1 - What is the scope of this subpart?
  • § 4.2 - How does FDA define key terms and phrases in this subpart?
  • § 4.3 - What current good manufacturing practice requirements apply to my combination product?
  • § 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
  • § 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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