When multiple facilities are involved in the processing of a Class III device, what must the PMA holder ensure regarding quality systems?

The correct answer underscores the regulatory requirement focusing on the quality systems associated with the design and manufacturing of medical devices. In the context of a Class III device, it is essential for the PMA (Premarket Approval) holder to ensure that the quality systems of the facility that is actually responsible for the design are compliant with the necessary regulatory standards. This is because the implementation of effective quality systems is crucial to ensure that the device maintains its safety and efficacy throughout its lifecycle.

While it may seem logical that all involved facilities need to have their quality systems documented and submitted, the primary responsibility lies with the design facility. Therefore, the PMA holder confirms that the quality system is adequate and compliant only for that facility, which covers the fundamental aspects of design and production. This streamlines regulatory processes by reducing the number of submissions necessary for facilities not directly responsible for design, focusing on what is most relevant for the approval process.

The other provided answer choices reflect additional considerations for the PMA holder, but they either deal with peripheral aspects or do not align directly with the regulatory obligation about the quality systems primarily linked to the design facility.