Public Meeting - Pediatric Medical Device Development - August 13-14, 2018, FDA White Oak Campus August 13 - 14, 2018

Public

• Date: August 13 - 14, 2018
• Time: 5:00 AM - 1:00 PM ET

• Organized By: Office of Communication and Education

 

The Food and Drug Administration (FDA) is announcing a Public Meeting entitled "Pediatric Medical Device Development." The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations.

Purpose

Medical device development for children continues to lag behind that for adults. The purpose of the meeting is to identify strategies that enhance the medical device ecosystem toward development and innovation of devices that serve the complex needs of children, and thereby accelerate medical device innovation for all Americans. As outlined in the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the meeting shall include consideration of ways to:

1. improve research infrastructure and research networks to facilitate the conduct of clinical studies of pediatric devices; (improve research infrastructure and research networks)
2. appropriately use extrapolation under section 515A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(b)); (appropriate use of extrapolation)
3. enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling; (appropriate use of postmarket registries)
4. increase FDA assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use; (Increase FDA assistance to pediatric device developers) and
5. identifying current barriers to pediatric device development and incentives to address such barriers. (identify current barriers and incentives)

The Agency invites all stakeholders, including representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note), medical provider organizations, and organizations and individuals representing patients and consumers to collaborate with us in addressing this important public health issue.

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• Date, Time and Location
• Federal Register Notice
• Webcast Archive
• Agenda [PDF - 718 KB]
• Speaker Biographies [PDF - 756 KB]
• Contact Us
• Important Resources / Background Information

Event Name in the App Directory - "Pediatric Medical Device Development

Download the Workshop App:

Mobile device URL: https://crowd.cc/s/1Syny

Laptop URL: https://crowd.cc/fdapediatrics2018 

Twitter: #devices4kids

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Date, Time and Location

This meeting was held on Monday, August 13, 2018 (9:00 am – 5:30 pm) and Tuesday, August 14, 2018 (8:30 am – 5:00 pm) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Webcast Archive

Day 1

• Part 1: https://collaboration.fda.gov/p4quypzc3p9/ (Network Issues)
• Part 2: https://collaboration.fda.gov/p6bxh3mga5q/
• Part 3: https://collaboration.fda.gov/p2ehv14d1v4/
• Part 4: https://collaboration.fda.gov/p9pv8iopdpq/
• Part 5: https://collaboration.fda.gov/p2rm0lh3y84/
• Part 6: https://collaboration.fda.gov/p52wu3tm2jm/

Day 2:

• Part 1: https://collaboration.fda.gov/p1ckfww548z/
• Part 2: https://collaboration.fda.gov/p515153slvd/
• Part 3: https://collaboration.fda.gov/p6nml3fuajt/
• Part 4: https://collaboration.fda.gov/p8iz5w27v23/
• Part 5: https://collaboration.fda.gov/p2ug3qzyd1j/

Presentations

• Session 1 - Intro Day 1, Part 1
• Session 2 - Intro Day 1, Part 2
• Session 3 - Intro Day 2, Part 1
• Session 4 - Intro Day 2, Part 2

Transcripts

• Day 1
• Day 2

Contact Us

For questions regarding workshop content please contact:

Victoria Wagman, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm.  5562, Silver Spring MD  20993, 301-796-6581, email:  Victoria.Wagman@fda.hhs.gov

Important Resources / Background Information

FDA Programs and Resources:

• FDA’s Efforts to Optimize Medical Device Innovation for Pediatrics [PDF - 124 KB]
• Pediatric Medical Device Homepage and Reports to Congress
• Pediatric Advisory Committee (PAC)
• Digital Health at CDRH, FDA
• Medical Device Development Tools (MDDT)
• Division of Industry and Consumer Education

FDA Guidance Documents:

The following guidance documents provide background information regarding pediatric medical device development:

• Premarket Assessment of Pediatric Medical Devices
• Providing Information about Pediatric Uses of Medical Devices
• Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
• Qualification of Medical Device Development Tools

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Event Materials

Title	File Type/Size
Pediatric Medical Device Development Public Meeting Transcript - Day 1	pdf (803.92 KB)
Pediatric Medical Device Development Public Meeting Transcript - Day 2	pdf (779.97 KB)