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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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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).

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[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR3.6]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 3 -- PRODUCT JURISDICTION

Subpart A - Assignment of Agency Component for Review of Premarket Applications

Sec. 3.6 Product jurisdiction officer.

The Office of Combination Products (Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930,, e-mail: combination@fda.gov, is the designated product jurisdiction officer.

[68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006; 75 FR 13678, Mar. 23, 2010]

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