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5 Steps to Get Medicare Coverage for Your IDE Clinical Trial

June 18, 2021

White Paper

CMS Coverage Playbook: How to Secure IDE Clinical Trial Reimbursement White Paper

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Post-market surveillance under a “522 order” — why, what, and how?

April 9, 2020

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Have You Considered an EUA for Your Diagnostic Test?

April 2, 2020

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Is the FDA’s EFS Program Right for Your Medical Device?

February 28, 2020

White Paper

Environmental and Social Considerations for Medical Devices

White Paper

Final FDA Guidance – Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

White Paper

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

White Paper

New FDA Guidance for Medical Device Reporting for Manufacturers