Understanding FDA’s Guidance on Medical Device Export Certificates

Introduction “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices” outlined in this document navigates the regulatory landscape established by the FDA Reauthorization Act of 2017 (FDARA), particularly Section 704, and the...

Regulatory Round-Up

With updates and guidance getting published constantly, it can be difficult to keep up with everything regulatory bodies come out with. On top of that, determining what is applicable to a specific device can be even more difficult.  This White Paper discusses...

FDA’s New Breakpoints in Device Labeling

Introduction to the Guidance  FDA issued a new guidance document “Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling”. The purpose of this guidance document, issued on September 29, 2023, is to inform industry of the...
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