Beginning January 4, 2020, registrants must submit registrations, registration renewals, updates,
or cancellations to FDA electronically, unless FDA has granted a waiver under 21 CFR 1.245
(see 21 CFR 1.231(a)(2) and (b), 1.234(d), and 1.235(d)).
If you are submitting a waiver from electronic submission of your registration, registration
renewal, update, or cancellation, you must submit a written request to FDA that explains why it
is not reasonable for you to submit a registration, registration renewal, update, or cancellation
electronically to FDA. Possible reasons for why it may not be reasonable will depend on the
circumstances, but in some cases may include conflicting religious beliefs or lack of reasonable
access to the Internet.
We encourage registrants seeking a waiver to submit their request in advance of the biennial
registration renewal because we experience an increased volume of industry queries during this
timeframe.
