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.


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.

Date, Time and Location

This meeting will be held on August 13 and 14, 2018, beginning at 9:00 a.m. to 5:00 p.m. at the following location:

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

Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed.


This meeting will be webcast. Registration is required.

Registration to Attend the Workshop

If you wish to attend this meeting, you must register by 4:00 p.m. on August 6, 2018.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

Attendance In-Person
     Mr. Mrs. Ms. None
(to select multiple degrees, hold down the CONTROL key while clicking.)
Please enter Email again for verification :
*  (No dashes or spaces in phone numbers please)

Requests to speak must be received by June 29, 2018. Please indicate the topic you
wish to speak about from the topics stated in the purpose of the workshop above.

Do you wish to make a presentation? Yes No




* = required field

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communications, Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5671,

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:

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: 03/01/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English