Part III: Computational Modeling Tools – Evaluating the Safety and Performance of Blood-Contacting Medical Devices. - Shared screen with speaker view
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Is there anyway for someone in the public to track who has used a given regulatory science tool? For example, could someone in the public identify the 30+ stakeholders who used the validation data for nozzles and pumps in their regulatory submissions?
Could you please share with us the validation technique?
Hey brent! Can you skip to the last slide? sorry!
Mostafa Ghoreyshi (You): Thank you for the talks. How do you evaluate submissions that do not have simulation data vs. the ones that do? Is that going to affect your evaluation in a positive or nevarive way?
Contact the Division of Industry and Consumer Education (DICE)https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice
Could you please comment on the best practices for a Q-Sub process to obtain feedback on planned modeling & credibility activities to support an FDA submission.
FDA Catalog of Regulatory Science Tools to Help Assess New Medical Deviceshttps://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatory-science-tools-help-assess-new-medical-devices
How do you evaluate submissions that do not have simulation data vs. the ones that do? Is that going to affect your evaluation in a positive or negative way?