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Post-market surveillance under a “522 order”: Why, how and what?

Company X has gained 510k clearance for their new heart valve, and was notified by the Food and Drug Administration (FDA) that post-market surveillance (PMS) is required. Why did they receive it, what is it and what does it mean, and how do they address it? You will know more after reading this article. Why? There are several routes for manufacturers to conduct PMS. It may be ordered by the FDA under a “522 order”. PMS under a 522-order is covered in Title 21 Part 822 of the CFR, and...

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Earn and Keep Your Market Share Through Reimbursement Support

Market adoption of new medical devices in the United States is largely dependent on the availability of an applicable CPT® code for use in reporting the services provided. Additionally, the existence of positive insurance medical policies outlining coverage for a...

Pre Market

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