What distinguishes a Traditional PMA from other submission methods?

A Traditional Premarket Approval (PMA) submission is characterized by its requirement to be submitted as a single, complete application. This method involves providing comprehensive data and evidence to demonstrate the safety and effectiveness of a medical device. The completeness of the Traditional PMA submission is crucial, as it must include all necessary information upfront, such as clinical study results, manufacturing details, and labeling information, allowing the FDA to conduct a thorough and standardized review.

This contrasts with other submission methods that may allow for phased or modular submissions over time or that might involve different regulatory requirements across multiple countries, potentially complicating the approval process. By requiring a full, singular submission, the Traditional PMA streamlines the process for evaluating the totality of evidence provided for the medical device at once, thereby enhancing the clarity and focus of the FDA's review.