Document ID: FDA-2016-N-0382-0001
Agency: fda
Document Type: Notice
Title: Building the National Evaluation System for Medical Devices: Using
Real-World Evidence To Improve Device Safety and Effectiveness;
Public Workshop; Request for Comments
Posted Date: 2016-02-16T05:00Z

[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7806-7807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02966]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0382]

Building the National Evaluation System for Medical Devices: 
Using Real-World Evidence To Improve Device Safety and Effectiveness; 
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), in collaboration with 
the University of Maryland Center of Excellence in Regulatory Science 
and Innovation, is announcing a public workshop titled ``Building the 
National Evaluation System for Medical Devices: Using Real-World 
Evidence to Improve Device Safety and Effectiveness.'' The objective of 
the workshop is to discuss the scientific progress being made in 
harnessing evidence generated from the real-world use of medical 
devices to improve device safety and effectiveness. A national 
evaluation system for medical devices, which leverages real-world 
evidence, can help FDA more efficiently strike the right balance 
between premarket and postmarket data collection, facilitate access to 
medical devices, and more quickly and robustly identify safety signals 
that may arise in the postmarket period. The promise of using real-
world evidence to promote the safety and effectiveness of medical 
devices can only be achieved through robust public-private partnerships 
and new approaches to informatics, epidemiology, biostatistics, and 
healthcare data systems integration.

DATES: The public workshop will be held on March 24, 2016, from 8:30 
a.m. to 4:30 p.m.

ADDRESSES: The public workshop will be held at the University of 
Maryland, Pharmacy Hall, 20 North Pine St., Baltimore, MD 21201. For 
additional travel and hotel information, please refer to 
www.pharmacy.umaryland.edu/DeviceEval. (FDA has verified the Web site 
addresses throughout this notice, but FDA is not responsible for 
subsequent changes to the Web sites after this document publishes in 
the Federal Register).
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0382 for ``Building the National Evaluation System for 
Medical Devices: Using Real-World Evidence to Improve Device Safety and 
Effectiveness; Public Workshop; Request for Comments''. Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ann Anonsen, University of Maryland, 
Fischell Department of Bioengineering, 2207 Jeong H. Kim Bldg., College 
Park, MD 20742, 301-405-0285, FAX: 304-405-9953, aanonsen@umd.edu; or 
Audrey Thomas, Office of Regulatory Science and Innovation, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, 
Silver Spring,

[[Page 7807]]

MD 20993-0002, Audrey.Thomas@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to 
discuss the scientific progress being made in harnessing evidence 
generated from the real-world use of medical devices to improve device 
safety and effectiveness. The role that unique device identification 
plays in improving device evaluation, to support more informed clinical 
and patient decision-making, and device innovation will also be 
discussed.
    The foundation (strategy and steps) for the development of a 
national evaluation system for medical devices has been developed by 
FDA's Center for Devices and Radiological Health (available at 
www.pharmacy.umaryland.edu/DeviceEval). In 2015, two multistakeholder 
groups issued reports that develop the science and provide 
recommendations that further the establishment of this system: 
``Building an Effective National Medical Device Surveillance System'' 
and ``Recommendations for a National Medical Device Evaluation System: 
Strategically Coordinated Registry Networks to Bridge the Clinical Care 
and Research'' (available at www.pharmacy.umaryland.edu/DeviceEval).
    To successfully harness relevant information from the diverse set 
of real-world evidence, the United States must develop the necessary 
infrastructure which is not yet in place today. We continue to explore 
ways to improve the efficiency and cost-effectiveness of data 
generation in traditional medical device clinical trials while 
maintaining data quality. The goal is to streamline the process and 
restore the United States to the country of first choice to conduct 
clinical research for medical technology innovation and ultimately 
bring their products first to U.S. patients. Limitations of current 
postmarket surveillance tools, such as passive reporting, also 
constrain ability to rapidly address safety concerns. A national 
evaluation system for medical devices, which leverages real-world 
evidence, can help FDA more efficiently strike the right balance 
between premarket and postmarket data collection, facilitate access to 
medical devices, and more quickly and robustly identify safety signals 
that may arise in the postmarket period. The promise of using real-
world evidence to promote the safety and effectiveness of medical 
devices can only be achieved through robust public-private partnerships 
and new approaches to informatics, epidemiology, biostatistics, and 
healthcare data systems integration.
    This workshop will provide clinicians, researchers, and others from 
the medical device industry, professional societies, health care 
delivery systems groups, patient advocacy groups, and FDA the 
opportunity to discuss this important topic.
    Agenda: The agenda is located at www.pharmacy.umaryland.edu/DeviceEval.
    Registration: There is a registration fee to attend this public 
workshop. The registration fee is charged to help defray the costs for 
facilities, materials, and food. Seats are limited and registration 
will be on a first-come, first-served basis.
    To register, please complete registration online at: 
www.pharmacy.umaryland.edu/DeviceEval. The costs of registration for 
the different categories of attendees are as follows:

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                        Category                               Cost
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Industry Representative.................................             $50
Charitable Nonprofit and Academic Other Than University               50
 of Maryland............................................
University of Maryland, College Park and Baltimore......               0
Government..............................................               0
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    Accommodations: Attendees are responsible for their own hotel 
accommodations. If you need special accommodations due to a disability, 
please contact Ann Anonsen (see FOR FURTHER INFORMATION CONTACT).

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02966 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P