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Frequently Asked Questions

All links provided below will direct you to the respective resource on the FDA website.

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What testing requirements/studies are needed to support an Investigational Device Exemption?

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Where can I find information on regulations for laboratory developed tests?

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Can my device be reviewed by FDA and Centers for Medicare and Medicaid Services (CMS) in parallel?

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Is my therapy eligible for the Regenerative Medicine Advanced Therapy (RMAT) designation?

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Updated Date: 
October 5, 2020