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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]
[CITE: 21CFR814.110]
 See Related Information on 814.110 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 814 -- PREMARKET APPROVAL OF MEDICAL DEVICES

Subpart H--Humanitarian Use Devices

Sec. 814.110 New indications for use.

(a) An applicant seeking a new indication for use of a HUD approved under this subpart H shall obtain a new designation of HUD status in accordance with 814.102 and shall submit an original HDE in accordance with 814.104.

(b) An application for a new indication for use made under 814.104 may incorporate by reference any information or data previously submitted to the agency under an HDE.
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