RAPS

FDA Final Rule Mandates Electronic Registration of Device Establishments

The US Food and Drug Administration (FDA) has issued a final rule regarding  electronic device registration and listing requirements, putting into practice a long-awaited rule combining the ...
Politifact

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.
RAPS

FDA proposes waiving device registration fees for firms making less than $1M, in bankruptcy

The US Food and Drug Administration (FDA) is proposing to use recently granted authority from Congress to waive annual registration fees for small medtech manufacturers making $1 million or less ...
Columbus Dispatch

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 ...
The Indianapolis Star

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

Vibroacoustic Products Listed as Class I Medical Devices; Red Light Therapy Products Listed as Class II Medical Devices LAS VEGAS, NV, UNITED STATES, February 3, 2026 ...