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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
- 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
- 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Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...
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Sharan Murugan
- Sep 23, 2022
- 1 min
USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...
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