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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, 2013]
[CITE: 21CFR814.108]
See Related Information on Supplemental applications. 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. 814.108 Supplemental applications.

After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under 814.39, except that a request for a new indication for use of a HUD shall comply with requirements set forth in 814.110. The timeframes for review of, and FDA action on, an HDE supplement are the same as those provided in 814.114 for an HDE.

[63 FR 59220, Nov. 3, 1998]

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