The FDA is hosting a public meeting to discuss pediatric medical device development at its White Oak Campus on August 13-14, 2018. Please join us in a discussion about strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. The FDA encourages the development of safe and effective medical devices for children through efficient pathways related to funding research and development; designing clinical trials; bringing lifesaving devices to market; and educating patients, providers, and others about the special needs of pediatric populations.
Meeting attendees will hear from and discuss with experts and stakeholders including patients, industry, health care providers, and academia about regulatory and economic structures to incentivize the development and marketing of medical devices for pediatric populations. Presentations and discussions will highlight existing programs, policies, and procedures developed by both the FDA and others in the pediatric community to improve the availability of devices specifically indicated for the pediatric populations.
The two-day public meeting will include presentations and interactive discussions about the following topics:
- Optimizing evidence generation- attendees will hear from Rachel Rath, Deputy Director for the National Evaluation System for Health Technology (NEST) Coordinating Center at the Medical Device Innovation Consortium about the NEST and incorporating Real World Evidence generation strategies into device development for pediatrics.
- Creating regulatory value and simplicity- attendees will hear from Lynne Yao, Director of Maternal and Pediatric Health at FDA’s Center for Drug Evaluation and Research, about what aspects of the pediatric drug development legislative and regulatory landscape may translate successfully to the device community.
- Developing a supportive marketplace- attendees will hear from Andrew Lo, Director of the Laboratory for Financial Engineering at the Massachusetts Institute of Technology about business models for supporting pediatric device development.
You can learn more about the interactive sessions and additional guest speakers by viewing theagenda.
There are in-person and webcast options available. Click here to register (registration is free). If you have any questions, do not hesitate to contact Victoria Wagman at 301-796-6581 or by email atVictoria.Wagman@fda.hhs.gov.
We hope to see you there!
Pediatric Medical Device Development Team
Center for Devices and Radiological Health
U.S. Food and Drug Administration