Title 21

PART 4

Part 4 - Regulation Of Combination Products

PART 4 - REGULATION OF COMBINATION PRODUCTS Authority:21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271. Source:78 FR 4321, Jan. 22, 2013, unless otherwise noted.

• Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.
• Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.

21:1.0.1.1.4.1	SUBPART A	Subpart A - Current Good Manufacturing Practice Requirements for Combination Products
21:1.0.1.1.4.1.63.1	SECTION 4.1	4.1 What is the scope of this subpart
21:1.0.1.1.4.1.63.2	SECTION 4.2	4.2 How does FDA define key terms and phrases in this subpart
21:1.0.1.1.4.1.63.3	SECTION 4.3	4.3 What current good manufacturing practice requirements apply to my combination product
21:1.0.1.1.4.1.63.4	SECTION 4.4	4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product
21:1.0.1.1.4.2	SUBPART B	Subpart B - Postmarketing Safety Reporting for Combination Products
21:1.0.1.1.4.2.63.1	SECTION 4.100	4.100 What is the scope of this subpart
21:1.0.1.1.4.2.63.2	SECTION 4.101	4.101 How does the FDA define key terms and phrases in this subpart
21:1.0.1.1.4.2.63.3	SECTION 4.102	4.102 What reports must you submit to FDA for your combination product or constituent part
21:1.0.1.1.4.2.63.4	SECTION 4.103	4.103 What information must you share with other constituent part applicants for the combination product
21:1.0.1.1.4.2.63.5	SECTION 4.104	4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part
21:1.0.1.1.4.2.63.6	SECTION 4.105	4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part

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