- July 15 - 16, 2019
8:00 AM - 9:00 AM ET
Event LocationWhite Oak Campus: The Great Room
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
- Organized By:
July 15, 2019
8 a.m. – 5 p.m.
July 16, 2019
9 a.m. – 1 p.m.
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled “Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review.” The purpose of this workshop is to provide an overview of key elements of regulatory submissions for these devices, and to facilitate education and communication between manufacturers and sponsors of these devices and the divisions in CBER that regulate them.
The public workshop will be held on July 15, 2019, from 8 a.m. to 5 p.m., and on July 16, 2019, from 9 a.m. to 1 p.m.
The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
This public workshop will also be webcast. Individuals who wish to view the webcast should register for the workshop. A link to the live webcast will be provided upon registration. All sessions, except for the individual meetings with staff at the end of day 1, will be webcast.
FOR FURTHER INFORMATION CONTACT:
Loni Warren Henderson or Sherri Revell, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-8010. For questions, email: CBERPublicEvents@fda.hhs.gov (subject line: OBRR IVD workshop).
The Office of Blood Research and Review (OBRR) is responsible for regulating in vitro diagnostic devices (IVDs) that are used in the manufacture of blood and blood components and in compatibility testing. The Division of Emerging and Transfusion-Transmitted Diseases (DETTD) is responsible for regulating IVDs that are used to test blood donations for infectious diseases that can be transmitted by blood and blood products, including HIV and HCV. The Division of Blood Components and Devices (DBCD) is responsible for regulating IVDs that are used to determine blood donor and recipient compatibility, such as ABO and human leukocyte antigen-typing devices. The goal of this workshop is to provide manufactures the opportunity to learn how FDA reviews these devices and engage with OBRR staff on general and device-specific issues related to Biologics License Application (BLA), Pre-Market Approval (PMA), and Pre-market notification (510(k)) submissions for these devices.
- Topics for Discussion at the Public Workshop
The first day of the workshop will include presentations by FDA covering topics of general applicability to device manufacturers, including submission types and timelines, investigational new drug applications and investigational device exemptions, pre-submission policies, CMC review, software, CLIA categorization, and pre-approval and pre-licensure inspection considerations. A question and answer session will follow the presentations.
The first session will be followed by presentations by FDA on topics of interest to manufacturers of devices that are intended to screen blood donations for infectious diseases, including special considerations around the design of analytical and clinical studies and validation of cadaveric claims. Note that HIV diagnostic devices will not be discussed at the workshop. Following the presentations, workshop attendees will have the opportunity to meet individually with DETTD staff for informal discussions (pre-registration is required).
The second day of the workshop will include presentations by FDA on topics of interest to manufacturers of devices that are intended for use for determining blood donor and recipient compatibility, including special considerations for these BLA, PMA, and 510(k) submissions. Following the presentations, there will be a question and answer session with FDA staff.
To facilitate discussion at the workshop, interested persons may submit questions in advance of the workshop. Please submit comments to CBERPublicEvents@fda.hhs.gov (insert subject line OBRR IVD workshop) by June 15, 2019.
To register for the public workshop, please visit the following website https://www.eventbrite.com/e/perspectives-on-in-vitro-diagnostic-devices-regulated-by-the-office-of-blood-research-and-review-tickets-60413409133.
Please provide complete contact information for each attendee, including name, title, affiliation, and email. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by June 28, 2019, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided, beginning at 7 a.m.
If you need special accommodations due to a disability, please contact Loni Warren Henderson or Sherri Revell no later than July 1, 2019 (see FOR FURTHER INFORMATION CONTACT). Request for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the event, no later than July 1, 2019. A request for either interpreting or captioning should be sent directly to the FDA Interpreting Services Staff email account: firstname.lastname@example.org.
Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.