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Navigating the Future of Laboratory Developed Tests - The Impact of New FDA Guidance

By Nicholas Smith

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.

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Reducing risks in IVD instrument development

By Nicholas Smith

The In Vitro Diagnostic (IVD) medical device market is one where new and advanced applications are appearing every day. Equipment expertise and regulations are becoming increasingly complex to the point that a diagnostic company may not be able to keep pace and bring their platform solution to market in a timely manner with the appropriate support level required by the customer.

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