1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
  6. Subpart H - Humanitarian Use Devices
  7. 21 CFR § 814.110
21 CFR § 814.110
New indications for use
June 25, 2020
CFR

(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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§ 814.108 Supplemental applications
Next
§ 814.112 Filing an HDE

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