§ 1.1110 What are the general requirements for submitting information to FDA under this subpart?

(a) All applications, reports, notifications, and records submitted to FDA under this subpart must be submitted electronically and in English unless otherwise specified. If FDA requests inspection or submission of records that are maintained in any language other than English, the recognized accreditation body or LAAF-accredited laboratory must provide an English translation within a reasonable time.

(b) A program applicant must provide any translation and interpretation services needed by FDA during the processing of the application, including during any onsite assessments of the applicant by FDA.