510(k)

FDA by the Numbers: 2023 Mid-Year Review
Medical Devices and Diagnostics Industry
Thu, 07/13/23 - 10:12 am
Medtech
FDA
devices
510(k)
7 Reasons for Medtech to Be Thankful in 2021
Medical Devices and Diagnostics Industry
Mon, 11/22/21 - 10:18 pm
devices
Medtech
hospitals
digital health
510(k)
in vitro diagnostics
Build Back Better
diversity
FDA shakes up hepatitis C testing market by opening up 510(k) pathway
Medtech Dive
Mon, 11/22/21 - 10:30 am
FDA
regulatory
diagnostics
hepatitis C
510(k)
Baxter, digital health startups lead pushback against 510(k) exemptions
BioPharma Dive
Tue, 03/23/21 - 10:55 am
devices
Baxter
FDA
510(k)
regulatory
digital health
FDA authorizes first COVID test via traditional review pathway
RAPS.org
Wed, 03/17/21 - 11:29 pm
FDA
510(k)
diagnostics
COVID-19
BioFire Diagnostics
What a new FDA commissioner could mean for clinical research
Mass Device
Tue, 04/2/19 - 11:29 pm
R&D
FDA
510(k)
Possible Major Changes to 510(k) Program Ahead
FDA Law Blog
Mon, 11/26/18 - 11:38 pm
devices
FDA
510(k)
FDA launches pilot to shorten some 510(k) approval times
Medical Design and Outsourcing
Tue, 10/2/18 - 07:38 pm
FDA
devices
510(k)
Is FDA Really Streamlining Its PMA and 510(k) Processes?
Medical Devices and Diagnostics Industry
Fri, 04/27/18 - 08:08 pm
devices
CE Mark
FDA
PMAs
510(k)
FDA exempts 1,003 Class II devices from 510(k) requirements
Mass Device
Sun, 07/16/17 - 03:47 pm
FDA
devices
class II medical devices
510(k)
FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements
RAPS.org
Tue, 07/11/17 - 09:38 am
devices
FDA
510(k)
class II medical devices
510(k) submissions to FDA declining
Emergo
Fri, 03/17/17 - 09:27 am
devices
510(k)
FDA
FDA Issues a Significantly Improved Draft Guidance Regarding 510(k) Modifications
FDA Law Blog
Mon, 08/29/16 - 09:11 am
FDA
devices
510(k)
US FDA finalizes 510(k) exemptions for some Class I and II medical devices
Mass Device
Mon, 07/6/15 - 10:30 am
FDA
devices
510(k)