80 FR 14402 - An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 53 (March 19, 2015)

Page Range		14402-14404
FR Document		2015-06278
Federal Register, Volume 80 Issue 53 (Thursday, March 19, 2015)
[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Pages 14402-14404]
From the Federal Register Online  [www.thefederalregister.org]
[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: 
[email protected].
    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: 
[email protected] 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.

[[Page 14404]]

     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
14402 Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices

MSC 7892, Bethesda, MD 20892, 301–379– DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
9351, allen.richon@nih.hhs.gov. HUMAN SERVICES HUMAN SERVICES
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR14–247: National Institutes of Health Food and Drug Administration
Pharmacogenetics, Pharmacoepigenetics and [Docket No. FDA–2015–N–0620]
Personalized Medicine in Children. National Heart, Lung, and Blood
Date: April 16, 2015. Institute; Notice of Closed Meetings
An Interactive Discussion on the
Time: 10:00 a.m. to 12:00 p.m. Pursuant to section 10(d) of the Clinical Considerations of Risk in the
Agenda: To review and evaluate grant Federal Advisory Committee Act, as Postmarket Environment; Public
applications. amended (5 U.S.C. App.), notice is Workshop; Request for Comments
Place: National Institutes of Health, 6701 hereby given of the following meetings.
Rockledge Drive, Bethesda, MD 20892, The meetings will be closed to the AGENCY: Food and Drug Administration,
(Telephone Conference Call). public in accordance with the HHS.
Contact Person: Elaine Sierra-Rivera, Ph.D., provisions set forth in sections ACTION: Notice of public workshop;
Scientific Review Officer, Center for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., request for comments.
Scientific Review, National Institutes of as amended. The grant applications,
Health, 6701 Rockledge Drive, Room 6184, The Food and Drug Administration
contract proposal, and the discussions (FDA) is announcing a public workshop
MSC 7804, Bethesda, MD 20892, 301–435– could disclose confidential trade secrets
1779, riverase@csr.nih.gov. entitled ‘‘Clinical Considerations of Risk
or commercial property such as in the Postmarket Environment.’’ The
Name of Committee: Center for Scientific patentable material, and personal
Review Special Emphasis Panel; Member
purpose of this workshop is to provide
information concerning individuals a forum for an interactive discussion on
Conflict: Ocular Diseases Pathophysiology associated with the grant applications or
and Therapeutic Approaches.
assessing changes in medical device risk
contract proposal, the disclosure of as quality and safety situations arise in
Date: April 16, 2015. which would constitute a clearly
Time: 10:00 a.m. to 3:00 p.m. the postmarket setting when a patient,
unwarranted invasion of personal operator, or member of the public uses
Agenda: To review and evaluate grant privacy.
applications. the device. FDA is interested in
Place: National Institutes of Health, 6701 Name of Committee: National Heart, Lung, obtaining input from stakeholders about
and Blood Institute Special Emphasis Panel; assessing risk postmarket when new
Rockledge Drive, Bethesda, MD 20892,
Clinical Research in HIV/HLB Diseases. hazards develop in the postmarket
(Virtual Meeting). Date: April 13, 2015.
Contact Person: Alessandra C Rovescalli, setting that were not present or not
Time: 8:00 a.m. to 5:00 p.m.
Ph.D., Scientific Review Officer, National Agenda: To review and evaluate grant known at the time of clearance or
Institutes of Health, Center for Scientific applications. approval or hazards were anticipated,
Review, 6701 Rockledge Drive, Rm. 5205 Place: The Dupont Circle Hotel, 1500 New but harm occurs at an unexpected rate
MSC7846, Bethesda, MD 20892, (301) 435– Hampshire Avenue NW., Washington, DC or in unexpected populations or use
1021, rovescaa@mail.nih.gov. 20036. environments. Comments and
Contact Person: Stephanie L Constant, suggestions generated through this
Name of Committee: Center for Scientific
Ph.D. Scientific Review Officer, Office of workshop will facilitate the assessment
Review Special Emphasis Panel; PAR–13– Scientific Review/DERA, National Heart,
190: Detection of Pathogen Induced Cancer. of risk in postmarket quality and safety
Lung, and Blood Institute, 6701 Rockledge
Date: April 17, 2015. Drive, Room 7189, Bethesda, MD 20892, 301–
situations.
Time: 12:00 p.m. to 6:00 p.m. 443–8784 constantsl@nhlbi.nih.gov. Date and Time: The public workshop
Agenda: To review and evaluate grant will be held on April 21, 2015, from
Name of Committee: National Heart, Lung,
applications. and Blood Institute Special Emphasis Panel; 8:30 a.m. to 5 p.m.
Place: National Institutes of Health, 6701 Improving Red Blood Cells for Transfusion. Location: The public workshop will
Rockledge Drive, Bethesda, MD 20892. Date: April 13, 2015. be held at FDA’s White Oak Campus,
Contact Person: Gagan Pandya, Ph.D., Time: 12:00 p.m. to 2:00 p.m. 10903 New Hampshire Ave., Building
Scientific Review Officer, National Institutes Agenda: To review and evaluate contract 31 Conference Center, the Great Room
of Health, Center for Scientific Review, 6701 proposals. (Rm. 1503), Silver Spring, MD 20993–
Place: National Institutes of Health, 6701 0002. Entrance for the public meeting
Rockledge Drive, Rm. 3200, MSC 7808,
Rockledge Drive, Room 7198, Bethesda, MD participants (non-FDA employees) is
Bethesda, MD 20892, 301–435–1167, 20892 (Telephone Conference Call).
pandyaga@mai.nih.gov. Contact Person: Kristin Goltry, Ph.D.
through Building 1 where routine
(Catalogue of Federal Domestic Assistance Scientific Review Officer, Office of Scientific security check procedures will be
Program Nos. 93.306, Comparative Medicine; Review/DERA, National Heart, Lung, and performed. For parking and security
93.333, Clinical Research, 93.306, 93.333, Blood Institute, 6701 Rockledge Drive, Room information, please refer to: http://
93.337, 93.393–93.396, 93.837–93.844, 7198, Bethesda, MD 20892, 301–435–0297, www.fda.gov/AboutFDA/
goltrykl@mail.nih.gov. WorkingatFDA/BuildingsandFacilities/
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance WhiteOakCampusInformation/
Program Nos. 93.233, National Center for ucm241740.htm.
Dated: March 13, 2015. Sleep Disorders Research; 93.837, Heart and Contact Person: Jean M. Cooper,
Anna Snouffer, Vascular Diseases Research; 93.838, Lung Center for Devices and Radiological
Diseases Research; 93.839, Blood Diseases
Deputy Director, Office of Federal Advisory Health, Food and Drug Administration,
and Resources Research, National Institutes
Committee Policy. 10903 New Hampshire Ave., Bldg. 66,
Rmajette on DSK2VPTVN1PROD with NOTICES

of Health, HHS)
[FR Doc. 2015–06268 Filed 3–18–15; 8:45 am] Rm. 5540, Silver Spring, MD 20993,
Dated: March 13, 2015. 301–796–6141, email: Jean.Cooper@
BILLING CODE 4140–01–P
Michelle Trout, fda.hhs.gov.
Program Analyst, Office of Federal Advisory Registration: Registration is free and
Committee Policy. available on a first-come, first-served
[FR Doc. 2015–06269 Filed 3–18–15; 8:45 am] basis. Persons interested in attending
BILLING CODE 4140–01–P this public workshop must register

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14404 Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices

• What factors are important to take which was published in the Federal Collection of Information
into account when conducting risk Register on March 6, 2015, 80 FR 12185. Title: Level 1 Assessment Form, Level
assessments of safety and quality issues The meeting has been cancelled due 3 Evaluation Form for Students, and
that occur with marketed medical to the reassignment of applications. Level 3 Evaluation Form for
devices? What principles best guide the Dated: March 13, 2015. Supervisors.
risk assessment process to assure timely, Anna Snouffer, Type of Information Collection:
consistent, and optimal results? Revision of currently approved
Deputy Director, Office of Federal Advisory
• Are there improvements that FDA Committee Policy. collection.
and stakeholders could make to enhance [FR Doc. 2015–06274 Filed 3–18–15; 8:45 am] Form Titles and Numbers: FEMA
risk assessments in recall and shortage Form 092–0–2, Level 1 Assessment
BILLING CODE 4140–01–P
situations with medical devices? Form; FEMA Form 092–0–2A, Level 3
• Are there specific activities or Evaluation Form for Students; FEMA
issues related to postmarket quality, Form 092–0–2B, Level 3 Evaluation
safety, or compliance activities where DEPARTMENT OF HOMELAND Form for Supervisors.
approaches used by FDA and industry SECURITY Abstract: The forms will be used to
currently differ enough to create survey the Center for Domestic
confusion or delay or limit appropriate Federal Emergency Management Preparedness (CDP) students enrolled in
public health actions? Please identify Agency CDP courses and their supervisors. The
them. surveys will collect information
• In which activities and areas of [Docket ID: FEMA–2014–0033; OMB No. regarding quality of instruction, course
postmarket quality, compliance, and 1660–0132] material, and impact of training on their
safety would more detailed policies or professional employment.
guidance be most useful? Agency Information Collection
Affected Public: State, Local or Tribal
At this public workshop, participants Activities: Submission for OMB
Government.
will engage in open dialogue to discuss Review; Comment Request
Estimated Number of Respondents:
the responses to issues raised by the AGENCY: Federal Emergency 44,600.
presenters and the questions in this Management Agency, DHS. Estimated Total Annual Burden
Federal Register notice. ACTION: Notice. Hours: 11,150.
III. Reference Estimated Cost: 403,795.25.
SUMMARY: The Federal Emergency Dated: March 13, 2015.
The following reference has been Management Agency (FEMA) will Terry Cochran,
placed on display in the Division of submit the information collection
Dockets Management (see ADDRESSES) Acting Director, Records Management
abstracted below to the Office of Division, Mission Support, Federal
and may be seen by interested persons Management and Budget for review and Emergency Management Agency, Department
between 9 a.m. and 4 p.m., Monday clearance in accordance with the of Homeland Security.
through Friday. We have verified all requirements of the Paperwork [FR Doc. 2015–06336 Filed 3–18–15; 8:45 am]
Web site addresses, but we are not Reduction Act of 1995. The submission BILLING CODE 9111–53–P
responsible for subsequent changes to will describe the nature of the
the Web sites after this document information collection, the categories of
publishes in the Federal Register. respondents, the estimated burden (i.e., DEPARTMENT OF HOMELAND
1. FDA, ‘‘Quality System (QS) Regulation/ the time, effort and resources used by SECURITY
Medical Device Good Manufacturing respondents to respond) and cost, and
Practices,’’ 2014, available at http:// the actual data collection instruments Federal Emergency Management
www.fda.gov/MedicalDevices/ FEMA will use. Agency
DeviceRegulationandGuidance/
DATES: Comments must be submitted on [Docket No. FEMA–2015–0001; Internal
PostmarketRequirements/
QualitySystemsRegulations/default.htm.
or before April 20, 2015. Agency Docket No. FEMA–B–1301]
ADDRESSES: Submit written comments
Dated: March 13, 2015. on the proposed information collection Proposed Flood Hazard
Leslie Kux, to the Office of Information and Determinations
Associate Commissioner for Policy. Regulatory Affairs, Office of
AGENCY: Federal Emergency
[FR Doc. 2015–06278 Filed 3–18–15; 8:45 am] Management and Budget. Comments
Management Agency; DHS.
BILLING CODE 4164–01–P
should be addressed to the Desk Officer
for the Department of Homeland ACTION: Notice; correction.
Security, Federal Emergency SUMMARY: On April 4, 2013, FEMA
DEPARTMENT OF HEALTH AND Management Agency, and sent via published in the Federal Register a
HUMAN SERVICES electronic mail to oira.submission@ proposed flood hazard determination
omb.eop.gov or faxed to (202) 395–5806. notice at 78 FR 20340 that contained a
National Institutes of Health FOR FURTHER INFORMATION CONTACT: table which included a Web page
Requests for additional information or address through which the Preliminary
Center for Scientific Review;
copies of the information collection Flood Insurance Rate Map (FIRM), and
Rmajette on DSK2VPTVN1PROD with NOTICES

Cancellation of Meeting
should be made to Director, Records where applicable, the Flood Insurance
Notice is hereby given of the Management Division, 500 C Street SW., Study (FIS) report for the communities
cancellation of the Center for Scientific Washington, DC 20472–3172, facsimile listed in the table could be accessed.
Review Special Emphasis Panel, April number (202) 212–4701, or email The information available through the
2, 2015, 1:00 p.m. to April 2, 2015, 2:00 address FEMA-Information-Collections- Web page address has subsequently
p.m., National Institutes of Health, 6701 Management@fema.dhs.gov. been updated. The table provided here
Rockledge Drive, Bethesda, MD, 20892 SUPPLEMENTARY INFORMATION: represents the proposed flood hazard

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Document Created: 2018-02-21 09:42:13
Document Modified: 2018-02-21 09:42:13
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop; request for comments.
FR Citation		80 FR 14402
80 FR 14402 - An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 53 (March 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
