The Overview of Harmonization by Doing HBD for

The Overview of Harmonization by Doing (HBD) for Children Nicole Gillette Division of Cardiovascular Devices Office of Device Evaluation CDRH/FDA

Disclosures • Nothing to disclose www. fda. gov 2

HBD for Children • Members consist of – Academia from Japan and US – Industry from Japan and US – Regulators from Japan and US www. fda. gov 3

Phase I • Understand clinical needs • Identify the current situation • Identify developmental barriers Phase II – Phase I 2017 – 2016 By Doing - 2018 4

Phase II • Categorized pediatric devices into 4 areas – Category 1: unapproved in Japan and approved in US – Category 2: unapproved in both Japan and US but used off-label – Category 3: unapproved in both Japan and US but approved in other countries – Category 4: devices under development Phase II – Phase I 2017 – 2016 By Doing - 2018 5

Phase II • Proof of concept (POC) – Medtronic’s Harmony Valve – Continuing to discuss other POCs • Discussed how to overcome hurdles – Japan Registries – US Registries Phase II – Phase I 2017 – 2016 By Doing - 2018 6

Summary • Studying the POC in both Japan and US • Continuing to brainstorm and implement ways to decrease lag time of pediatric cardiovascular products • If interested in joining, please let us know! 7

Contact Information: Nicole. Gillette@fda. hhs. gov Tel: (240) 402 -6630