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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...
Sharan Murugan
Jul 13, 20242 min read
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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...
Sharan Murugan
Jan 9, 20241 min read
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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...
Sharan Murugan
Oct 14, 20231 min read
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![USFDA Guidance: Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_453363554d4e4263424363~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_avif,quality_auto/nsplsh_453363554d4e4263424363~mv2.webp)
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...
Sharan Murugan
Sep 10, 20232 min read
24 views
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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,...
Sharan Murugan
Feb 21, 20232 min read
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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_399,h_300,fp_0.50_0.50,q_90,enc_avif,quality_auto/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.webp)
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Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...
Sharan Murugan
Jan 17, 20231 min read
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