Document ID: FDA-2015-N-0620-0001
Agency: fda
Document Type: Notice
Title: An Interactive Discussion on the Clinical Considerations of Risk in the
Postmarket Environment; Public Workshop; Request for Comments
Posted Date: 2015-03-19T04:00Z

[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Pages 14402-14404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06278]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0620]

An Interactive Discussion on the Clinical Considerations of Risk 
in the Postmarket Environment; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Clinical Considerations of Risk in the Postmarket 
Environment.'' The purpose of this workshop is 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 uses the device. FDA is 
interested in obtaining input from stakeholders about assessing risk 
postmarket when new hazards develop in the postmarket setting that were 
not present or not known at the time of clearance or approval or 
hazards were anticipated, but harm occurs at an unexpected rate or in 
unexpected populations or use environments. Comments and suggestions 
generated through this workshop will facilitate the assessment of risk 
in postmarket quality and safety situations.
    Date and Time: The public workshop will be held on April 21, 2015, 
from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the 
public meeting participants (non-FDA employees) is through Building 1 
where routine security check procedures will be performed. For parking 
and security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: 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.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register

[[Page 14403]]

online by 4 p.m., April 13, 2015. Early registration is recommended 
because facilities are limited and, therefore, FDA may limit the number 
of participants from each organization. If time and space permits, 
onsite registration on the day of the public workshop will be provided 
beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
susan.monahan@fda.hhs.gov no later than April 7, 2015.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone 
number. Those without Internet access should contact Susan Monahan (see 
Registration). Registrants will receive confirmation after they have 
been accepted and will be notified if they are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Web cast. Persons interested in viewing the Web cast must 
register online by 4 p.m., April 13, 2015. Early registration is 
recommended because Web cast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Web cast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after April 14, 2015. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in 
this document, but FDA is not responsible for any subsequent changes to 
the Web sites after this document publishes in the Federal Register.)
    Request to Speak: This public workshop includes a public comment 
session and topic-focused sessions. During online registration, you may 
indicate if you wish to speak during a public comment session and which 
topic you wish to address. FDA has included general topics in this 
document. FDA will do its best to accommodate requests to make public 
comments. Individuals and organizations with common interests are urged 
to consolidate or coordinate their presentations and request time for a 
joint presentation. Following the close of registration, FDA will 
determine the amount of time allotted to each speaker and will select 
and notify speakers by April 16, 2015. All requests to speak must be 
received by the close of registration on April 13, 2015. If selected to 
speak, any presentation materials must be emailed to Jean Cooper (see 
Contact Person) no later than April 13, 2015. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public workshop.
    Comments: FDA is seeking input from FDA staff, medical device 
industry, standards organizations, health care providers, academia, 
patients, and other stakeholders. FDA is soliciting written or 
electronic comments on all aspects of the workshop topics. The deadline 
for submitting comments related to this public workshop is May 19, 
2015.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question you are addressing. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION: 

I. Background

    There is a strong desire by FDA and industry to harmonize their 
practices regarding assessment of risk in postmarket quality and safety 
situations including, but not limited to, product defects, failures, 
faults, or shortages, and any resulting harm. When postmarket safety or 
quality issues arise, both the firm and FDA conduct risk analyses of 
the device in order to decide what actions to take. During this 
analysis, firms typically look for changes from their preproduction 
risk analysis to their postmarket experience and apply or update their 
risk management plan as appropriate. In contrast, FDA responds to the 
same issue by assessing information submitted in the firm's premarket 
submission and may consider other information such as information 
collected during an inspection when it is available. The result is that 
FDA and industry may base their decisions about postmarket quality and 
safety on different information.
    Managing risk does not mean eliminating risk. The medical device 
industry, FDA, doctors, and patients recognize that medical devices 
cleared or approved for market may pose some inherent risk, even when 
used appropriately according to labeling. Examples include, but are not 
limited to, manufacturing problems, materials changes, unanticipated 
design flaws, regional differences in clinical practice, measurement 
inaccuracies, incomplete instructions, transport and storage factors, 
and incorrect installation.
    FDA anticipates that principles and factors developed with public 
input will help bridge differences in understanding when conducting 
risk assessments.

II. Topics for Discussion at the Public Workshop

    FDA held discussions in the Fall of 2014 with a working group of 
the Association of Advancement of Medical Instrumentation to develop a 
draft list of risk principles and factors to consider in analyzing 
postmarket risk. The draft principles and factors will be presented for 
discussion at the public meeting. The purpose of this workshop is to 
provide a forum for a collaborative discussion on postmarket risk 
principles and factors assessing risk when changes occur due to 
postmarket quality and safety situations. The following questions are 
provided to optimize the discussion.

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     What factors are important to take into account when 
conducting risk assessments of safety and quality issues that occur 
with marketed medical devices? What principles best guide the risk 
assessment process to assure timely, consistent, and optimal results?
     Are there improvements that FDA and stakeholders could 
make to enhance risk assessments in recall and shortage situations with 
medical devices?
     Are there specific activities or issues related to 
postmarket quality, safety, or compliance activities where approaches 
used by FDA and industry currently differ enough to create confusion or 
delay or limit appropriate public health actions? Please identify them.
     In which activities and areas of postmarket quality, 
compliance, and safety would more detailed policies or guidance be most 
useful?
    At this public workshop, participants will engage in open dialogue 
to discuss the responses to issues raised by the presenters and the 
questions in this Federal Register notice.

III. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday. We have 
verified all Web site addresses, but we are not responsible for 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.

1. FDA, ``Quality System (QS) Regulation/Medical Device Good 
Manufacturing Practices,'' 2014, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm.

    Dated: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06278 Filed 3-18-15; 8:45 am]
 BILLING CODE 4164-01-P