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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, 2014]
[CITE: 21CFR821.20]
See Related Information on Devices subject to tracking. 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 821 -- MEDICAL DEVICE TRACKING REQUIREMENTS

Subpart B--Tracking Requirements

Sec. 821.20 Devices subject to tracking.

(a) A manufacturer of any class II or class III device that fits within one of the three criteria within 821.1(a) must track that device in accordance with this part, if FDA issues a tracking order to that manufacturer.

(b) When responding to premarket notification submissions and remarket approval applications, FDA will notify the sponsor by issuing an order that states that FDA believes the device meets the criteria of section 519(e)(1) of the act and, by virtue of the order, the sponsor must track the device.

[67 FR 5951, Feb. 8, 2002]

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