Blog

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

April 9, 2020

Blog

Have You Considered an EUA for Your Diagnostic Test?

April 2, 2020

Blog

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