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Dpp 106a Form

Dpp 106a Form

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Se we've gotten clear on the 510(k) process. Let's switch to PMA. Can you give us the basics there? Sure, the PMA is a process through which the FDA evaluates and approves novel new technologies for marketing. The agency must find them to be both safe and effective, and then they can be called approved by FDA. PMAs apply to all new devices for which there is no predicate, to devices that pose a significant risk to patients, and to devices that are similar to the Class III devices that were put on the market prior to 1976, when the device law was enacted and for which the FDA has now called for PMA's, so pacemakers would be an example. This is the highest regulatory category of FDA review.

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