Regulatory Blog

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Jul 132 min read

USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD

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

Jan 91 min read

USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions

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

Oct 14, 20231 min read

USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

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

Sep 10, 20232 min read

USFDA Guidance: Premarket Notification [510(k)] Submissions

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

Feb 21, 20232 min read

USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices

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

Jan 16, 20231 min read

USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions

Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...