CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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

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?

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?

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.