[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Notices]
[Pages 45538-45540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0865]
The Patient Preference Initiative: Incorporating Patient
Preference Information Into the Medical Device Regulatory Processes:
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 the following
public workshop entitled ``The Patient Preference Initiative:
Incorporating Patient Preference Information into the Medical Device
Regulatory Processes.'' The purpose of the workshop is to discuss ways
to incorporate patient preferences on the benefit-risk tradeoffs of
medical devices into the full spectrum of the Center for Devices and
Radiological Health (CDRH) regulatory decision making. It also aims to
advance the science of measuring treatment preferences of patients,
caregivers, and health care providers. The information learned from
this workshop and public comments will benefit regulators, industry,
providers, patients, and device innovators.
Date and Time: The public workshop will be held on September 18 and
19, 2013, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Section A
of the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance
for 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: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
Contact Person: Nada Hanafi, Center for Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, rm. 3623, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5427, 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 online by September 11, 2013, 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the workshop will be available beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan (email: [email protected] or 301-796-
5661) no later than September 4, 2013.
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
([email protected], 301-796-5661) to register. Registrants will
receive confirmation after they have been accepted. You will be
notified if you are on a waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by September 11, 2013, 4 p.m.
[[Page 45539]]
Early registration is recommended because Webcast connections are
limited. Organizations are requested to register all participants, but
to view using one connection per location. Webcast participants will be
sent technical system requirements after registration and will be sent
connection access information after September 12, 2013. 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.)
Comments: FDA is holding this public workshop to obtain information
on incorporating patient preferences into medical device regulatory
processes. In order to permit the widest possible opportunity to obtain
public comment, FDA is soliciting either electronic or written comments
on all aspects of measuring patient preference. FDA invites
stakeholders to submit their ideas before, during, or after the
workshop. The deadline for submitting comments related to this public
workshop is October 18, 2013. FDA is also soliciting comments and
information for inclusion in the workshop materials. To ensure adequate
time for review and incorporation prior to the workshop, FDA encourages
stakeholders to submit preliminary information by August 19, 2013.
This public workshop also includes an oral public comment session.
FDA intends to allow a 45-minute session for interested stakeholders to
raise questions and topics for consideration by the Agency.
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
CDRH is committed to giving patients in the United States access to
high-quality, safe, and effective medical devices of public health
importance first in the world. A key step toward this goal is to
improve the predictability, consistency, and transparency of the
premarket review process. In 2012, CDRH published the guidance document
entitled ``Factors to Consider When Making Benefit-Risk Determinations
in Medical Device Premarket Approval and De Novo Classifications'' (77
FR 18828; March 28, 2012). This guidance document outlines the
principal factors FDA considers when making benefit-risk determinations
during the premarket review process for certain medical devices,
including data on patient perspectives on meaningful benefits and
acceptable risks.
While the benefit-risk guidance outlines a strategy for including
patient preference data in the premarket review process, it does not
outline which methods, tools, and approaches could be used to collect
this information or provide guidance on how to establish and evaluate
the validity of evidence necessary for regulatory consideration.
Moreover, it is necessary to determine how patient preference data may
be used in a broader context of the total product life cycle (TPLC) of
medical devices. In addition to the benefit-risk determination, patient
preference measurements may also play an important role in device
innovation and postmarket analysis. For example, patient
dissatisfaction with the side effects of a currently marketed device
may suggest the need for postmarket studies, regulatory actions, or may
identify an opportunity to develop novel device design features.
CDRH has established the Patient Preference Initiative to provide
the information, guidance, and framework necessary to incorporate
patient preferences on the benefit-risk tradeoffs of medical devices
into the full spectrum of CDRH regulatory processes and to inform
medical device innovation by the larger medical device community. In
the process, the initiative aims to advance the science of measuring
medical device preferences of patients, caregivers, and providers. Once
the Patient Preference Initiative helps to define or refine the methods
to measure patient preference, CDRH seeks to incorporate patient views
into the TPLC of medical devices.
Patients have unique perspectives about the value of the probable
benefits and the impact of potential risks of medical devices.
Scientists, clinicians, device developers, and regulators play critical
roles in understanding the operation of medical devices and the
associated benefits and risks. But only patients live with their
medical conditions and need to make the choices required for their
care. In order to properly take these views into account, investigators
must have reliable and accurate methods, tools, and approaches.
Definition of Patient Preference: A composite measurement of
patient perceptions or expectations of potential benefits and risks of
a purported medical device, measured across the full spectrum of
patients who may be exposed to the device. The spectrum should include
the full variety of disease presentation, the exposure to the devices,
and the demographics of the target or affected patient populations.
II. Topics for Discussion at the Public Workshop
FDA is holding this public workshop to discuss incorporating
patient preference information into pre- and postmarket regulatory
processes. FDA intends to engage and solicit information from
stakeholders on (1) approaches (methods, tools and validation) for
capturing, collecting, and validating patient preference information;
and (2) the incorporation of patient preference information into
regulatory review processes.
In addressing these issues, FDA encourages stakeholders to consider
and comment on these questions:
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1. How to identify patients and their preferences
What type of information can/should patients provide?
What types of information do patients use to formulate
decisions about their treatment options?
Where can patient preference information be found?
2. What approaches should be used to collect patient preference
information?
What methods and tools can be used?
What are the relative strengths and limitations of these
methods and tools?
Who should collect patient preference information?
3. How to validate patient preference data and information
What methods and tools can be used?
Who should validate patient preference information?
4. How to incorporate patient preference information in the regulatory
process
How can FDA use patient preference data within the Total
Product Life Cycle regulatory paradigm?
In what ways should it not be used?
What additional safeguards should FDA consider when
including patient preference information into its regulatory decision
making?
Dated: July 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18080 Filed 7-26-13; 8:45 am]
BILLING CODE 4160-01-P