The Food and Drug Administration (FDA) announced a public Workshop entitled “Clinical Considerations of Risk in the Postmarket Environment."
The purpose of the workshop was to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket setting when a patient, operator, or member of the public actually uses the device.
This meeting was held April 21, 2015, beginning at 8:30 a.m. (EDT) to 5:00 p.m. (EDT) at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
|8:30-8:45||Welcome and Introduction||Kimber Richter (FDA/CDRH)|
|8:45-9:35||Introduction to Benefit and Risk Concepts||Jean Cooper (FDA/CDRH)|
|9:35-9:55||Post Market Quality and Safety Overview||Kristina Donohue (FDA/CDRH)|
|9:55-10:15||CDRH Office of Compliance|
Postmarket Risk Assessments
|Kimberly Brown Smith (FDA/CDRH)|
|10:30-10:50||Industry Perspective on Post Market Risk Assessment and Management||Tony Carr (industry)|
|10:50-11:15||One Approach to Risk Decision Analysis||Adam Seiver (industry)|
|11:15-12:00||AAMI White Paper||Mary Logan (AAMI)|
|12:00-1:00||Lunch||Boxed lunches from Sodexo (pre-order and pre-pay at registration in the morning)|
|1:00-2:15||Panel Addressing Questions in FR Notice||Ginger Glaser (chair/industry)|
Kate Bent (FDA/ORA)
Ralph Hall (academics)
Jeff Natterman (hospital)
Karen Smith (patient advocate)
Panel to hear comments
Registration is closed as of April 13, 2015.
Onsite registration will be available. For all registration questions please contact Susan Monahan at email@example.com or 301-796-5661.
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.
If you wish to make a comment during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that comments focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed 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.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, firstname.lastname@example.org.
For questions regarding workshop content please contact: Jean M. Cooper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5540, Silver Spring MD 20993, 301-796-6141, email: Jean.Cooper@fda.hhs.gov.