Which document contains detailed information on the safety and effectiveness of a Class III medical device?

The Pre-market Approval (PMA) application is the correct document that contains detailed information on the safety and effectiveness of a Class III medical device. This comprehensive document is required by the U.S. Food and Drug Administration (FDA) before a Class III device can be marketed. The PMA submission includes extensive data from clinical trials, manufacturing processes, and labeling, as well as evidence that supports the claim of safety and efficacy for the intended use of the device.

The focus of the PMA is to provide a thorough analysis and verification of the product's clinical findings, thus ensuring that the device meets stringent regulatory standards. It is a pivotal part of the FDA's regulatory process for high-risk medical devices.

In contrast, the other options do not provide the same level of detail specifically for Class III devices. The clinical evaluation report may summarize clinical data for a device but does not encompass the level of information mandated for a PMA. The Premarket Notification (510(k)) is used for devices that are not significantly different from existing devices and is generally applicable to Class I and Class II devices, making it inadequate for Class III devices that require PMA. A Quality Management System (QMS) manual outlines the processes for manufacturing and quality assurance within a company but