CFR Subpart E

CFR Subpart E
in effect

21 C.F.R. § 830.300 Devices subject to device identification data submission requirements.

(a) In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI). (b) Voluntary submission of information. If a labeler voluntarily includes a UDI on the label of a device under § 801.40, the labeler may also voluntarily submit information concerning that device under this part. (c) Exclusions. FDA may reject or remove any device identification data where: (1) The device identifier submitted does not conform to § 830.20; (2) The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States, (3) The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part, (4) The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance; (5) A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or (6) FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.

21 C.F.R. § 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.

21 C.F.R. § 830.320 Submission of unique device identification information.

(a) Designation of contact for device identification. Each labeler must designate an individual to serve as the point of contact with FDA on matters relating to the identification of medical devices marketed by the labeler. The contact for device information is responsible for ensuring FDA is provided with all information required by this part. The contact for device information may authorize an issuing agency or any other person to provide information to FDA on behalf of the labeler. (b) Information shall be submitted via electronic means. All information required by this subpart shall be submitted electronically to FDA's Global Unique Device Identification Database (GUDID) in a format that we can process, review, and archive, unless the labeler has obtained a waiver from electronic submission of unique device identifier (UDI) data. (c) Waiver from electronic submission. (1) A labeler may request a waiver from electronic submission of UDI data by submitting a letter addressed to the appropriate Center Director explaining why electronic submission is not technologically feasible; send the request by email to: udi@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002. (2) If the establishment where the labeler is located has obtained a waiver from electronic submission of registration and listing information under section 510(p) of the Federal Food, Drug, and Cosmetic Act, the labeler is deemed to have a waiver from electronic submission of UDI data. (3) A labeler that has a waiver from electronic submission of UDI data must send a letter containing all of the information required by § 830.310, as well as any ancillary information permitted to be submitted under § 830.340 that the labeler wishes to submit, within the time permitted by § 830.330, addressed to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.

21 C.F.R. § 830.330 Times for submission of unique device identification information.

(a) The labeler shall submit to FDA the information required by § 830.310 no later than the date the label of the device must bear a unique device identifier under § 801.20 of this chapter. (b) The labeler of a device shall submit to FDA an update to the information required by § 830.310 whenever the information changes. The updated information must be submitted no later than the date a device is first labeled with the changed information. If the information does not appear on the label of a device, the updated information must be submitted within 10 business days of the change.

21 C.F.R. § 830.340 Voluntary submission of ancillary device identification information.

(a) You may not submit any information to the Global Unique Device Identification Database (GUDID) other than that specified by § 830.310, except where FDA acts to permit the submission of specified additional types of information, termed ancillary information. (b) FDA will provide information through the FDA Web site at http://www.fda.gov/udi/ concerning the types of ancillary information that may be submitted to the GUDID. (c) FDA may periodically change the types of ancillary information that may be submitted to the GUDID. We will announce any change on the FDA Web site at http://www.fda.gov/udi/ at least 60 days before making the change.

21 C.F.R. § 830.350 Correction of information submitted to the Global Unique Device Identification Database.

(a) If FDA becomes aware that any information submitted to the Global Unique Device Identification Database (GUDID) appears to be incorrect or potentially misleading, we may notify the labeler of the specific information that appears to be incorrect, and request that the labeler provide corrected information or explain why the information is correct. The labeler must provide corrected information or provide a satisfactory explanation of why the information is correct within 30 days of receipt of FDA's notification. (b) If the labeler does not respond to FDA's notification within 30 days of receipt, or if FDA determines, at any time, that any information in the GUDID is incorrect or could be misleading, we may delete or correct the information. Any action taken by FDA under this paragraph does not relieve the labeler of its responsibility under paragraph (a) of this section to provide corrected information or an explanation of why the information previously submitted is correct.

21 C.F.R. § 830.360 Records to be maintained by the labeler.

(a) Each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device identifier. These records must be retained for 3 years from the date the labeler ceases to market the version or model. (b) Compliance with this section does not relieve the labeler of the need to comply with recordkeeping requirements of any other FDA regulation.

Starting a business? Corpus forms LLCs in all 50 states and DC.