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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR830.310]
See Related Information on Information required for unique device identification. 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 830 -- UNIQUE DEVICE IDENTIFICATION

Subpart E--Global Unique Device Identification Database

Sec. 830.310 Information required for unique device identification.

The contact for device identification designated under 830.320(a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label:

(a) Concerning the labeler:

(1) The name of the labeler;

(2) A telephone number or email address that will allow FDA to communicate with the contact for device identification designated under 830.320(a); and

(3) The name of each issuing agency whose system is used by the labeler to assign UDIs used by the labeler.

(b) Concerning each version or model of a device with a UDI on its label:

(1) The device identifier portion of the UDI assigned to the version or model;

(2) When reporting a substitution of a new device identifier that will be used in lieu of a previously reported identifier, the device identifier that was previously assigned to the version or model;

(3) If 801.45 of this chapter requires the device to bear a UDI as a permanent marking on the device itself, either:

(i) A statement that the device identifier that appears as a permanent marking on the device is identical to that reported under paragraph (b)(1) of this section, or

(ii) The device identifier portion of the UDI that appears as a permanent marking on the device;

(4) The proprietary, trade, or brand name of the device as it appears on the label of the device;

(5) Any version or model number or similar reference that appears on the label of the device;

(6) If the device is labeled as sterile, a statement to that effect;

(7) If the device is labeled as containing natural rubber latex that contacts humans, or is labeled as having packaging containing natural rubber latex that contacts humans, as described by 801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a statement to that effect;

(8) Whether a patient may be safely exposed to magnetic resonance imaging, nuclear magnetic resonance imaging, or magnetic resonance tomography while using the device, or while the device is implanted in patient.

(9) If the device is available in more than one size, the size of the particular version or model, together with the unit of measure, as it appears on the label of the device;

(10) The type of production identifiers that appear on the label of the device;

(11) The FDA premarket submission number of a cleared or approved device, or a statement that FDA has by regulation exempted the device from premarket notification;

(12) The FDA listing number assigned to the device;

(13) The Global Medical Device Nomenclature (GMDN) term or code for the device;

(14) The total number of individual devices contained in the device package.

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