[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, [email protected]; 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, [email protected].
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]
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