§807.34. Summary of requirements for owners or operators granted a waiver from submitting required information electronically. — Inbound Citations

(c) Those owners or operators who have obtained a waiver from filing registration and listing information electronically should refer to § 807.34 for information on how to submit such information by postal mail.

(a) All owners or operators that are subject to the registration and listing requirements of this part shall provide such information to us by using the FDA electronic device registration and listing system, unless granted a waiver from electronic submission in accordance with § 807.21(b). Electronic submissions of registration and listing information must comply with part 11 of this chapter, except for the requirements in § 11.10(b), (c), and (e), and the corresponding requirements in § 11.30 of this chapter. Those owners or operators granted a waiver from electronic submission should refer to paragraphs (c) and (g) of this section and § 807.34 for instructions on how to submit device registration and listing information.