Times for submission of unique device identification information.

21 C.F.R. § 830.330
in effectEffective: 2024-07-01
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(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.

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