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Electronic Code of Federal Regulations

e-CFR data is current as of February 14, 2020

Title 21Chapter ISubchapter APart 4


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A—GENERAL

PART 4—REGULATION OF COMBINATION PRODUCTS

rule

Subpart A—CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS FOR 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?
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Subpart B—POSTMARKETING SAFETY REPORTING FOR COMBINATION PRODUCTS

§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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