Medical Devices

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

Image of a baby in an incubator.
 
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.


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

Download the Workshop App:
Mobile device URL: https://crowd.cc/s/1Syny
Twitter: #devices4kids

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

Day 2:

Presentations

Transcripts

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 Guidance Documents:

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

Page Last Updated: 10/04/2018
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