A company is filing for PMA of a Class III device. What information must be included in the submission?

The best choice for what must be included in a Premarket Approval (PMA) submission for a Class III medical device is a Summary of Studies. A PMA application requires comprehensive data demonstrating the safety and effectiveness of the device. This includes results from clinical trials and other studies that evaluate the performance of the device under real-world conditions.

Such summaries provide the regulatory authorities with crucial insights into the methodology, outcomes, and overall context of the studies conducted. They help reviewers assess the device's risks and benefits comprehensively, which is critical for Class III devices due to their higher risk classification under the regulatory framework.

In contrast, the other options do not accurately reflect the required components of a PMA submission. Bioequivalence information generally pertains to generic drug approvals rather than Class III devices. Electronic CTD specifications are used primarily for drug applications and not specifically relevant for devices. A Paragraph IV Certification is pertinent to Abbreviated New Drug Applications (ANDAs) for generics, where a company certifies that their product does not infringe on a patent; this is not applicable to a PMA submission. Thus, a Summary of Studies is essential as it consolidates pivotal research findings necessary for regulatory review and decision-making.