510(k)

FDA by the Numbers: 2023 Mid-Year Review
FDA by the Numbers: 2023 Mid-Year Review
Medical Devices and Diagnostics Industry
Medtech
FDA
devices
510(k)
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7 Reasons for Medtech to Be Thankful in 2021
7 Reasons for Medtech to Be Thankful in 2021
Medical Devices and Diagnostics Industry
devices
Medtech
hospitals
digital health
510(k)
in vitro diagnostics
Build Back Better
diversity
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FDA shakes up hepatitis C testing market by opening up 510(k) pathway
FDA shakes up hepatitis C testing market by opening up 510(k) pathway
Medtech Dive
FDA
regulatory
diagnostics
hepatitis C
510(k)
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Baxter, digital health startups lead pushback against 510(k) exemptions
Baxter, digital health startups lead pushback against 510(k) exemptions
BioPharma Dive
devices
Baxter
FDA
510(k)
regulatory
digital health
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FDA authorizes first COVID test via traditional review pathway
FDA authorizes first COVID test via traditional review pathway
RAPS.org
FDA
510(k)
diagnostics
COVID-19
BioFire Diagnostics
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What a new FDA commissioner could mean for clinical research
What a new FDA commissioner could mean for clinical research
Mass Device
R&D
FDA
510(k)
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Possible Major Changes to 510(k) Program Ahead
Possible Major Changes to 510(k) Program Ahead
FDA Law Blog
devices
FDA
510(k)
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FDA launches pilot to shorten some 510(k) approval times
FDA launches pilot to shorten some 510(k) approval times
Medical Design and Outsourcing
FDA
devices
510(k)
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Is FDA Really Streamlining Its PMA and 510(k) Processes?
Is FDA Really Streamlining Its PMA and 510(k) Processes?
Medical Devices and Diagnostics Industry
devices
CE Mark
FDA
PMAs
510(k)
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FDA exempts 1,003 Class II devices from 510(k) requirements
FDA exempts 1,003 Class II devices from 510(k) requirements
Mass Device
FDA
devices
class II medical devices
510(k)
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FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements
FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements
RAPS.org
devices
FDA
510(k)
class II medical devices
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510(k) submissions to FDA declining
510(k) submissions to FDA declining
Emergo
devices
510(k)
FDA
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FDA Issues a Significantly Improved Draft Guidance Regarding 510(k) Modifications
FDA Issues a Significantly Improved Draft Guidance Regarding 510(k) Modifications
FDA Law Blog
FDA
devices
510(k)
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US FDA finalizes 510(k) exemptions for some Class I and II medical devices
US FDA finalizes 510(k) exemptions for some Class I and II medical devices
Mass Device
FDA
devices
510(k)
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