Source: http://www.law.cornell.edu/cfr/text/21/814.110
Timestamp: 2014-08-20 07:19:54
Document Index: 78503267

Matched Legal Cases: ['art 814', '§ 814', '§ 814', '§ 814', '§ 814', '§ 351', '§ 352', '§ 353', '§ 360', '§ 360', '§ 360', '§ 360', '§ 221', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371', '§ 372', '§ 373', '§ 374', '§ 374', '§ 375', '§ 379', '§ 381']

21 CFR 814.110 - New indications for use. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 814 › Subpart H › Section 814.110 21 CFR 814.110 - New indications for use.
§ 814.110
New indications for use.
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.
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.
U.S. Code: Title 21 - FOOD AND DRUGS§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 353 - Exemptions and consideration for certain drugs, devices, and biological products§ 360 - Registration of producers of drugs or devices§ 360c - Classification of devices intended for human use§ 360d - Performance standards§ 360e - Premarket approval21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,§ 360f - Banned devices§ 360g - Judicial review§ 360h - Notification and other remedies§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 371 - Regulations and hearings§ 372 - Examinations and investigations§ 373 - Records§ 374 - Inspection§ 374a - Inspections relating to food allergens§ 375 - Publicity§ 379 - Confidential information§ 381 - Imports and exports