miércoles, 26 de agosto de 2020

REMINDER: FDA Webinar: Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway


https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-regulatory-overview-developers-and-sponsors-neurological-and-physical-medicine-devices?utm_campaign=2020-08-26%20CDRH%20-%20Reminder%20Aug%2027%20Neuro%20De%20Novo%20Webinar&utm_medium=email&utm_source=Eloqua

Webinar Reminder: Join us Tomorrow for a Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway


On Thursday, August 27, 1:00 p.m.-2:30 p.m. ET, the U.S. Food and Drug Administration (FDA) will host a webinar for developers and manufacturers of neurological and physical medicine devices on the De Novo pathway, a potential pathway to market new medical devices for which there is no legally marketed predicate device.

This webinar will provide:
  • An introduction to the FDA’s role in facilitating innovation in neurological and physical medicine device technology.
  • An overview of the De Novo classification process.
  • Information on working with the FDA and the pre-submission process.

Questions?

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