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Sharan Murugan
Jul 13, 20242 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...
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![USFDA Guidance: Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_453363554d4e4263424363~mv2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_auto/nsplsh_453363554d4e4263424363~mv2.jpg)
Sharan Murugan
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...
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![USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_auto/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg)
Sharan Murugan
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Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...
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Sharan Murugan
Sep 23, 20221 min read
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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