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How many days from the date of assembly do we have to submit a 2579 to the customer state and FDA?
Federal regulations (Section 21 CFR 1020.30(d)) require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly (Form FDA 2579) to FDA within 15 days following the completion of the assembly.
Where do I send my FDA 2579?
How Is an FDA 2579 Submitted? The engineer should send the original and three carbon copies to the following locations: White Original \u2013 Mail to the FDA. Yellow copy \u2013 Mail to State Radiology Health Department.
Where do I send my FDA 2579?
How Is an FDA 2579 Submitted? The engineer should send the original and three carbon copies to the following locations: White Original \u2013 Mail to the FDA. Yellow copy \u2013 Mail to State Radiology Health Department.
How many days from the date of assembly do we have to submit a 2579 to the customer state and FDA?
Federal regulations (Section 21 CFR 1020.30(d)) require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly (Form FDA 2579) to FDA within 15 days following the completion of the assembly.
What is an FDA Form 2579?
The report of assembly (Form 2579) represents the assemblers certification that the system or component(s) are of the type called for by the Standard (i.e., certified), have been assembled according to the instructions provided by the manufacturer, and meets the requirements of the applicable Federal standards ...
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21 CFR § 1002.1 - Applicability. - Legal Information Institute
3Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3). 4Systems records and reports are ...
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