JD Supra

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
Tallahassee Democrat

inHarmony Announces FDA Registration Across Vibroacoustic and Red Light Therapy Product Lines

LAS VEGAS, NV, UNITED STATES, February 3, 2026 /EINPresswire.com/ — inHarmony Interactive, a leader in sound, vibration, and relaxation technology, has achieved U.S ...