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Sharan Murugan
- Jul 13
- 2 min
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...
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Sharan Murugan
- Jan 9
- 1 min
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...
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Sharan Murugan
- Oct 14, 2023
- 1 min
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...
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Sharan Murugan
- Sep 10, 2023
- 2 min
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...
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Sharan Murugan
- Feb 21, 2023
- 2 min
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,...
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Sharan Murugan
- Jan 17, 2023
- 1 min
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Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...
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