Tag: medical device

Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5

https://seetharamkandarpa.webnode.in/news/half-year-report-2013-fda-medical-devices-warning-letter-statistics-2-new-deficiency-group-in-the-top-5/

New FDA Guidelines for Medical Devices

https://seetharamkandarpa.webnode.in/news/new-fda-guidelines-for-medical-devices/

FDA publishes Guidance for Industry on "Investigation Device Exemptions"

https://seetharamkandarpa.webnode.in/news/fda-publishes-guidance-for-industry-on-investigation-device-exemptions/

New Developments in the EU with regard to Medical Devices

https://seetharamkandarpa.webnode.in/news/new-developments-in-the-eu-with-regard-to-medical-devices/

FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

https://seetharamkandarpa.webnode.in/news/fda-will-participate-in-a-medical-devices-single-audit-pilot-programme-in-2014/

Updates on Medical Device Regulations

https://seetharamkandarpa.webnode.in/news/updates-on-medical-device-regulations/

Boston Scientific's Watchman stroke-fighting device wins overwhelming FDA panel support

https://seetharamkandarpa.webnode.in/news/boston-scientifics-watchman-stroke-fighting-device-wins-overwhelming-fda-panel-support/

Overview of new CDRH Guidelines

https://seetharamkandarpa.webnode.in/news/overview-of-new-cdrh-guidelines/

FDA plans Changes to the Classification of Medical Devices

https://seetharamkandarpa.webnode.in/news/fda-plans-changes-to-the-classification-of-medical-devices/

FDA published Medical Device Recall Report

https://seetharamkandarpa.webnode.in/news/fda-published-medical-device-recall-report/

FDA published Guidance for Industry on "Investigation Device Exemptions (IDE)"

https://seetharamkandarpa.webnode.in/news/fda-published-guidance-for-industry-on-investigation-device-exemptions-ide-/