Join FDA experts on November 5, 2019 for a live workshop and Q&A about Device Classification and Custom Devices

On Tuesday, November 5, CDRH’s Division of Industry and Consumer Education (DICE) will host an Industry Basics Workshop on these final guidance documents: “Section 513(g) Requests for Information” and “Custom Device Exemption.” One of first steps on the marketing pathway for a medical device is to determine the classification of the product. A 513(g) Request for Information can assist with these determinations. In addition, in certain circumstances, patients and physicians may have unique physiology or pathology and need a custom device. The Industry Basics Workshop will address each topic in a one-hour session. Each session will feature a presentation followed by a moderated question and answer session with a panel of FDA experts. Audience participants are encouraged to email or call with questions during each session.

Workshop Details: There is no fee, and registration is not required. Date: Tuesday, November 5, 2019 Time: 1:00 – 3:00 pm ET You may choose to participate in one or both sessions. Each session will begin at the scheduled time below: 1:00 – 2:00pm ET: Section 513(g) Requests for Information 2:00 – 3:00pm ET: Custom Device Exemptions

On the day of the workshop, use the following link to join the webinar: http://fda.yorkcast.com/webcast/Play/626be66734eb406f986cdda0005a306a1d 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. If you have any questions regarding the Industry Basics Workshop, please contact CDRH’s DICE at DICE@fda.hhs.gov. We look forward to your participation on Tuesday, November 5. Thank You, Elias Mallis Director Division of Industry and Consumer Education