U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. News & Events (Medical Devices)
  4. Workshops & Conferences (Medical Devices)
  5. CDRH Industry Basics Workshop: 513(g) Requests for Information and Custom Device Exemption - November 5, 2019 - 11/05/2019 - 11/05/2019
  1. Workshops & Conferences (Medical Devices)

Workshop

Event Title
CDRH Industry Basics Workshop: 513(g) Requests for Information and Custom Device Exemption - November 5, 2019
November 5, 2019

Date:
November 5, 2019
Time:
1:00 PM - 3:00 PM ET
TAKE OUR SURVEY
Tell us what you think about the workshop

Workshop Materials

Workshop Summaries

Section 513(g) Requests for Information – One of the first steps on the marketing pathway for a medical device is to classify your device. As technology and innovation continue to advance, determining how to classify a device can be complex and challenging. This session will provide information on interacting with FDA for device determination and an introduction to Section 513(g) Requests - a mechanism to obtain FDA’s feedback for device determination and classification.

Custom Device Exemptions – In certain circumstances, patients and physicians may have unique physiology or pathology, and may need a custom device.  This session will provide an introduction to the FDA’s regulatory requirements for a custom device exemption.

Each session will include a presentation, followed by a moderated Q&A with a panel of CDRH experts. Audience participants are encouraged to email or call with questions during each session.

There is no fee to attend and registration is not required.

Participants may choose one or both sessions. Each session will begin at the scheduled time.

  • 1:00 – 2:00pm ET: Section 513(g) Requests for Information
  • 2:00 – 3:00pm ET: Custom Device Exemptions

Target Audience: All medical device industry and Health Care Providers

How to Join the Workshop:
On November 5, 2019, use the following link to join the webinar: http://fda.yorkcast.com/webcast/Play/626be66734eb406f986cdda0005a306a1d

The November 5, 2019, CDRH Industry Basics Workshop is as a general educational forum. It is not intended to provide submission-specific feedback, so please limit your questions to broad policy questions about the program topics.  Prior to the workshop we encourage you to view these CDRH Learn modules about Is My Product a Medical Device and How is My Medical Device Classified.

For questions about this program, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices at dice@fda.hhs.gov.

Event Materials

Title File Type/Size
Slides - Section 513(g) Request for Information pdf (380.18 KB)
Slides - Custom Device Exemptions pdf (395.14 KB)