Medical Devices

Public Workshop - An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment - April 21, 2015

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.

Date, Time and Location:

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

FDA Campus Information

8:30-8:45Welcome and IntroductionKimber Richter (FDA/CDRH)
8:45-9:35Introduction to Benefit and Risk ConceptsJean Cooper (FDA/CDRH)
9:35-9:55Post Market Quality and Safety OverviewKristina Donohue (FDA/CDRH)
9:55-10:15CDRH Office of Compliance
Postmarket Risk Assessments
Kimberly Brown Smith (FDA/CDRH)
10:30-10:50Industry Perspective on Post Market Risk Assessment and ManagementTony Carr (industry)
10:50-11:15One Approach to Risk Decision AnalysisAdam Seiver (industry)
11:15-12:00AAMI White PaperMary Logan (AAMI)
12:00-1:00LunchBoxed lunches from Sodexo (pre-order and pre-pay at registration in the morning)
1:00-2:15Panel Addressing Questions in FR NoticeGinger Glaser (chair/industry)
Kate Bent (FDA/ORA)
Ralph Hall (academics)
Jeff Natterman (hospital)
Karen Smith (patient advocate)

Public Comment

ADA-EASD-Diabetes Technology Commission (AEDTC): Statement On Insulin Pumps Robert E. Ratner, MD

A Risk Decision Analysis, CDRH

Four Failed Regulatory Checkpoints for Medical Device Safety in the United States, Hooman Noorchashm MD, PhD

Panel to hear comments

4:30-5:00Wrap upPanel
Registration to Attend the Workshop:

Registration is closed as of April 13, 2015.

Onsite registration will be available. For all registration questions please contact Susan Monahan at 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,


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:

Page Last Updated: 06/16/2015
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