Has this started yet?

Will this recording be available afterwards?

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?

Will the recording be available to show to others in the organization

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?

Please reach out to nhlbi_sbir@mail.nih.gov 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?