premarket approval

FDA Finalizes Guidance on Weight-Loss Devices

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

Digital Sponsors

Become a Sponsor

What's New

Mastering Radiated Emissions Testing: Tips for Success in EMC Compliance

FCC Adds Foreign-Made Consumer Routers to Covered List

NIST Releases Two New CSF Quick-Start Guides

When to Re-Test

FCC Removes Certain Drones from Covered List

- From Our Sponsors -