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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Can a manufacturer hook up a printer or monitor to its FFDM unit if the printer or monitor were not part of its original Pre-Market Approval (PMA)?

Policy Guidance Help System logoManufacturers will need to check the exact wording of their PMA to see if this is allowed. However, the facility is not restricted by the PMA and may hook up and use printers and monitors other than those approved by FDA for use with the manufacturer's FFDM unit as long as they meet the requirements specified in "Can a facility use printers and monitors that were not specifically approved as part of its FFDM unit?".

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