[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Pages 45538-45540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18080]



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.


    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: 
    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: susan.monahan@fda.hhs.gov 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 
(susan.monahan@fda.hhs.gov, 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 
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).


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:

[[Page 45540]]

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 

     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 

     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 

    Dated: July 23, 2013.
 Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18080 Filed 7-26-13; 8:45 am]