NHLBI – FDA Regulatory Science Tools Webinar - Speaker view
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How does a company qualify for these SEED services?
Can we have a cope of he slides.
Are there any standardized workflow that can be used for "AI-based models for diagnosis"?
What would be the first step for us as a innovator/small business - to get those workflows? Do we contact you?
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Where can we order a catalog?
Question for Dr. Margerrison: To what extent has FDA evaluated changes in review times or postmarket performance of devices that use MDDTs in their regulatory submissions?
We have a AI-based model for Mental Disorder Diagnosis - who must we contact to get things rolling at FDA? Is there a co-ordinator or someone who can serve as a primary contact person?
How do we request mentor(s) for SBIR Phs II awardee?
The catalog is on our external website at https://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatory-science-tools-help-assess-new-medical-devices
Can the RST be used for implantable class III device?
For Dr. Margerrison: How do you think use of the novel RSTs will affect regulatory approval of a medical device outside the US, particularly for the EU and countries covered by the MDSAP?
Juliet Sidique (She/Her)
Please reach out to email@example.com regarding product development services and mentoring
Can you provide ballpark figure of the budget one must have when seeking FDA approval for a new medical device?