Clinical Evaluation Systematic Literature Review - Apec-ahc.org
Clinical Evaluation Systematic Literature Review - Apec-ahc.org
Clinical Evaluation Systematic Literature Review - Apec-ahc.org
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US FDA Paper PMA<br />
• A “Paper PMA” is one that is based on bench testing<br />
and/or information derived from peer-reviewed<br />
scientific literature.<br />
• “Objective performance criteria” are performance<br />
criteria based on broad sets of data from historical<br />
databases (e.g., literature or registries) that are<br />
generally recognized as acceptable values. These<br />
criteria may be used for surrogate or clinical<br />
endpoints in demonstrating the safety or<br />
effectiveness of a device<br />
Summary<br />
• <strong>Clinical</strong> trials should be required based on a risk<br />
assessment of the individual device, not based on<br />
the classification of the devices<br />
• In most cases, clinical data collected through a<br />
variety of means is sufficient for proving safety and<br />
efficacy of medical devices as there is no scientific<br />
rationale for requiring a local or regional clinical<br />
trials<br />
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