Beginning January 4, 2020, you must submit your registration, registration renewal, updates, and
cancellations to FDA electronically unless FDA has granted a waiver from such requirement (see
21 CFR 1.231(a)(2) and (b), 1.234(d), and 1.235(d)). Furthermore, as we stated in the
Registration Final Rule, FDA must have already granted a waiver in order for the electronic
submission requirement to not apply (see 81 FR 45912 at 45943 to 45944).
