§ 830.330. Times for submission of unique device identification information.
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/us/cfr/t21/s§ 830.330·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.