SDRAN Virtual Program Event

Strategic FDA Engagement in Accelerated Pathways: Breakthrough, STeP, TAP & RAPID

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Event Details

Register for this Event

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Event Agenda

12:00 – 12:10 PM	Welcome & Speaker Introduction
12:10 – 12:50 PM	Speaker Presentation
12:50 – 1:00 PM	Live Q&A

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Program Overview

Early and strategic engagement with the FDA can significantly impact the success and timeline of innovative medical device development. This presentation will explore how companies can effectively navigate accelerated pathways including the Breakthrough Devices Program, STeP, TAP, and the newly announced RAPID pathway.

Attendees will gain practical insight into:

This session is ideal for professionals in Regulatory Affairs, Clinical Affairs, Product Development, and Medical Device Innovation.

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Speaker Biography

Michael Nilo is the Founder and Principal Consultant of Nilo Medical Consulting Group, where he advises medical device, biotechnology, and pharmaceutical companies on regulatory strategy and FDA submissions.

A former FDA lead reviewer, Michael brings more than 15 years of experience spanning both the Agency and industry. He has supported numerous Breakthrough Designation, STeP, and TAP submissions and regularly represents industry during FDA Sprint discussions.

His expertise includes pre-IDE, 510(k), HDE, IDE, and PMA submissions, with specialized experience in cardiovascular and combination products.

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Questions

For questions regarding the event or to pre-submit questions for the Q&A session, please contact: