harming individuals. Bringing critical appraisal questions concerning coherence, consistency, strength of association, and precision of the estimate into observational or post hoc analysis studies will allow evidence to be moved closer toward adequate and convincing levels.

Piper said that there is no one blueprint to follow in all situations. The analysis for long QT syndrome was different from the analysis for Oncotype DX, for example. The analysis must be adapted to the clinical setting and the evidence needed for that particular application. The bottom line is to establish that there is evidence of improved patient outcomes. One does not stop at clinical validity and associational evidence, Piper said.

Becker agreed that there is a fair amount of commonality about the kind of evidence that helps in reaching a decision. One of the things that sets the FDA approach apart from the approaches that can be employed in other settings, he said, is that the agency needs to look at tests on a deviceby-device, test-by-test basis and make regulatory decisions about the individual test that the device sponsor has brought to the agency. Stakeholders outside of FDA are more able to synthesize information across the literature and across tests. However, there are some circumstances in which FDA can handle class-specific issues across all of the devices of a particular type, rather than individually for each specific test.

Participants encouraged including subject matter experts in the process of evidence analysis. While such experts may not be part of the final evidence decision, they should be part of the gathering of the evidence.

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