Regulatory Blog

In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “ Transfer of a Premarket Notification...

The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...

Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research...

The Center for Devices and Radiological Health released multiple guidances earlier today (21-February-2023), related to "Laser Products,...

Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...