81_FR_7836 81 FR 7806 - Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness; Public Workshop; Request for Comments

81 FR 7806 - Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 30 (February 16, 2016)

Page Range7806-7807
FR Document2016-02966

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.

Federal Register, Volume 81 Issue 30 (Tuesday, February 16, 2016) 
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7806-7807]
From the Federal Register Online  [www.thefederalregister.org]
[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:

------------------------------------------------------------------------
                        Category                               Cost
------------------------------------------------------------------------
Industry Representative.................................             $50
Charitable Nonprofit and Academic Other Than University               50
 of Maryland............................................
University of Maryland, College Park and Baltimore......               0
Government..............................................               0
------------------------------------------------------------------------

    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

7806 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices listed nominees. Only organizations ADDRESSES: The public workshop will Workshop; Request for Comments’’. vote in the selection process. Persons be held at the University of Maryland, Received comments will be placed in who nominate themselves to serve as Pharmacy Hall, 20 North Pine St., the docket and, except for those voting or nonvoting consumer Baltimore, MD 21201. For additional submitted as ‘‘Confidential representatives will not participate in travel and hotel information, please Submissions,’’ publicly viewable at the selection process. refer to www.pharmacy.umaryland.edu/ http://www.regulations.gov or at the This notice is issued under the DeviceEval. (FDA has verified the Web Division of Dockets Management Federal Advisory Committee Act (5 site addresses throughout this notice, between 9 a.m. and 4 p.m., Monday U.S.C. app. 2) and 21 CFR part 14, but FDA is not responsible for through Friday. relating to advisory committees. subsequent changes to the Web sites • Confidential Submissions—To Dated: February 8, 2016. after this document publishes in the submit a comment with confidential Jill Hartzler Warner, Federal Register). information that you do not wish to be Associate Commissioner for Special Medical You may submit comments as made publicly available submit your Programs. follows: comments only as a written/paper [FR Doc. 2016–03010 Filed 2–12–16; 8:45 am] Electronic Submissions submission. You should submit two BILLING CODE 4164–01–P Submit electronic comments in the copies total. One copy will include the following way: information you claim to be confidential • Federal eRulemaking Portal: http:// with a heading or cover note that states DEPARTMENT OF HEALTH AND ‘‘THIS DOCUMENT CONTAINS www.regulations.gov. Follow the HUMAN SERVICES CONFIDENTIAL INFORMATION.’’ The instructions for submitting comments. Comments submitted electronically, Agency will review this copy, including Food and Drug Administration the claimed confidential information, in including attachments, to http:// [Docket No. FDA–2016–N–0382] www.regulations.gov will be posted to its consideration of comments. The the docket unchanged. Because your second copy, which will have the Building the National Evaluation claimed confidential information comment will be made public, you are System for Medical Devices: Using redacted/blacked out, will be available solely responsible for ensuring that your Real-World Evidence To Improve for public viewing and posted on comment does not include any Device Safety and Effectiveness; http://www.regulations.gov. Submit confidential information that you or a Public Workshop; Request for both copies to the Division of Dockets Comments third party may not wish to be posted, such as medical information, your or Management. If you do not wish your AGENCY: Food and Drug Administration, anyone else’s Social Security number, or name and contact information to be HHS. confidential business information, such made publicly available, you can ACTION: Notice of public workshop; as a manufacturing process. Please note provide this information on the cover request for comments. that if you include your name, contact sheet and not in the body of your information, or other information that comments and you must identify this SUMMARY: The Food and Drug identifies you in the body of your information as ‘‘confidential.’’ Any Administration (FDA), in collaboration comments, that information will be information marked as ‘‘confidential’’ with the University of Maryland Center posted on http://www.regulations.gov. will not be disclosed except in of Excellence in Regulatory Science and • If you want to submit a comment accordance with 21 CFR 10.20 and other Innovation, is announcing a public with confidential information that you applicable disclosure law. For more workshop titled ‘‘Building the National do not wish to be made available to the information about FDA’s posting of Evaluation System for Medical Devices: public, submit the comment as a comments to public dockets, see 80 FR Using Real-World Evidence to Improve written/paper submission and in the 56469, September 18, 2015, or access Device Safety and Effectiveness.’’ The manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/ objective of the workshop is to discuss Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/ the scientific progress being made in default.htm. harnessing evidence generated from the Written/Paper Submissions Docket: For access to the docket to real-world use of medical devices to Submit written/paper submissions as read background documents or the improve device safety and effectiveness. follows: electronic and written/paper comments A national evaluation system for • Mail/Hand delivery/Courier (for received, go to http:// medical devices, which leverages real- written/paper submissions): Division of www.regulations.gov and insert the world evidence, can help FDA more Dockets Management (HFA–305), Food docket number, found in brackets in the efficiently strike the right balance and Drug Administration, 5630 Fishers heading of this document, into the between premarket and postmarket data Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts collection, facilitate access to medical • For written/paper comments and/or go to the Division of Dockets devices, and more quickly and robustly submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. identify safety signals that may arise in Management, FDA will post your 1061, Rockville, MD 20852. the postmarket period. The promise of comment, as well as any attachments, using real-world evidence to promote except for information submitted, FOR FURTHER INFORMATION CONTACT: Ann the safety and effectiveness of medical marked and identified, as confidential, Anonsen, University of Maryland, devices can only be achieved through mstockstill on DSK4VPTVN1PROD with NOTICES if submitted as detailed in Fischell Department of Bioengineering, robust public-private partnerships and ‘‘Instructions.’’ 2207 Jeong H. Kim Bldg., College Park, new approaches to informatics, Instructions: All submissions received MD 20742, 301–405–0285, FAX: 304– epidemiology, biostatistics, and must include the Docket No. FDA– 405–9953, aanonsen@umd.edu; or healthcare data systems integration. 2016–N–0382 for ‘‘Building the National Audrey Thomas, Office of Regulatory DATES: The public workshop will be Evaluation System for Medical Devices: Science and Innovation, Food and Drug held on March 24, 2016, from 8:30 a.m. Using Real-World Evidence to Improve Administration, 10903 New Hampshire to 4:30 p.m. Device Safety and Effectiveness; Public Ave., Bldg. 1, Rm. 4220, Silver Spring, VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1

Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7807 MD 20993–0002, Audrey.Thomas@ epidemiology, biostatistics, and Pilot Project(s) under the Drug Supply fda.hhs.gov. healthcare data systems integration. Chain Security Act (DSCSA).’’ This SUPPLEMENTARY INFORMATION: The This workshop will provide public workshop will provide a forum purpose of this public workshop is to clinicians, researchers, and others from for discussing proposed design discuss the scientific progress being the medical device industry, objectives of pilot projects that will made in harnessing evidence generated professional societies, health care explore and evaluate methods to from the real-world use of medical delivery systems groups, patient enhance the safety and security of the devices to improve device safety and advocacy groups, and FDA the pharmaceutical distribution supply effectiveness. The role that unique opportunity to discuss this important chain. FDA would like to obtain device identification plays in improving topic. information and input from interested device evaluation, to support more Agenda: The agenda is located at pharmaceutical distribution supply informed clinical and patient decision- www.pharmacy.umaryland.edu/ chain members about issues related to making, and device innovation will also DeviceEval. utilizing the product identifier for be discussed. Registration: There is a registration fee product tracing, improving the technical The foundation (strategy and steps) to attend this public workshop. The capabilities of the supply chain, and for the development of a national registration fee is charged to help defray identifying the system attributes that are evaluation system for medical devices the costs for facilities, materials, and necessary to implement the has been developed by FDA’s Center for food. Seats are limited and registration requirements established under the Devices and Radiological Health will be on a first-come, first-served DSCSA. The information gathered from (available at basis. the workshop and the public comments www.pharmacy.umaryland.edu/ To register, please complete submitted to the docket will further DeviceEval). In 2015, two registration online at: inform FDA’s development of its pilot multistakeholder groups issued reports www.pharmacy.umaryland.edu/ project program. that develop the science and provide DeviceEval. The costs of registration for DATES: The public workshop will be recommendations that further the the different categories of attendees are held on April 5, 2016, from 9 a.m. to 5 establishment of this system: ‘‘Building as follows: p.m. and April 6, 2016, from 9 a.m. to an Effective National Medical Device 12:15 p.m. The deadline for submitting Surveillance System’’ and Category Cost either electronic or written comments ‘‘Recommendations for a National Industry Representative ........ $50 on this workshop is April 21, 2016. See Medical Device Evaluation System: Charitable Nonprofit and the SUPPLEMENTARY INFORMATION section Strategically Coordinated Registry Academic Other Than Uni- for registration date and information. Networks to Bridge the Clinical Care versity of Maryland ............ 50 ADDRESSES: The public workshop will and Research’’ (available at University of Maryland, Col- be held at FDA’s White Oak Campus, www.pharmacy.umaryland.edu/ lege Park and Baltimore ... 0 10903 New Hampshire Ave., Bldg. 31 DeviceEval). Government .......................... 0 Conference Center, the Great Room (Rm. To successfully harness relevant 1503A), Silver Spring, MD 20993–0002. information from the diverse set of real- Accommodations: Attendees are Entrance for the confirmed public world evidence, the United States must responsible for their own hotel workshop participants (non-FDA develop the necessary infrastructure accommodations. If you need special employees) is through Building 1 where which is not yet in place today. We accommodations due to a disability, routine security check procedures will continue to explore ways to improve the please contact Ann Anonsen (see FOR be performed. For parking and security efficiency and cost-effectiveness of data FURTHER INFORMATION CONTACT). information, please refer to http:// generation in traditional medical device Dated: February 9, 2016. www.fda.gov/AboutFDA/ clinical trials while maintaining data Leslie Kux, WorkingatFDA/BuildingsandFacilities/ quality. The goal is to streamline the Associate Commissioner for Policy. WhiteOakCampusInformation/ process and restore the United States to [FR Doc. 2016–02966 Filed 2–12–16; 8:45 am] ucm241740.htm. the country of first choice to conduct You may submit comments as BILLING CODE 4164–01–P clinical research for medical technology follows: innovation and ultimately bring their products first to U.S. patients. Electronic Submissions DEPARTMENT OF HEALTH AND Limitations of current postmarket HUMAN SERVICES Submit electronic comments in the surveillance tools, such as passive following way: reporting, also constrain ability to Food and Drug Administration • Federal eRulemaking Portal: http:// rapidly address safety concerns. A www.regulations.gov. Follow the national evaluation system for medical [Docket No. FDA–2016–N–0407] instructions for submitting comments. devices, which leverages real-world Proposed Pilot Project(s) Under the Comments submitted electronically, evidence, can help FDA more efficiently Drug Supply Chain Security Act; including attachments, to http:// strike the right balance between Public Workshop; Request for www.regulations.gov will be posted to premarket and postmarket data Comments the docket unchanged. Because your collection, facilitate access to medical comment will be made public, you are mstockstill on DSK4VPTVN1PROD with NOTICES devices, and more quickly and robustly AGENCY: Food and Drug Administration, solely responsible for ensuring that your identify safety signals that may arise in HHS. comment does not include any the postmarket period. The promise of ACTION: Notice of public workshop; confidential information that you or a using real-world evidence to promote request for comments. third party may not wish to be posted, the safety and effectiveness of medical such as medical information, your or devices can only be achieved through SUMMARY: The Food and Drug anyone else’s Social Security number, or robust public-private partnerships and Administration (FDA) is announcing a confidential business information, such new approaches to informatics, public workshop entitled ‘‘Proposed as a manufacturing process. Please note VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1


Document Created: 2016-02-13 03:13:37
Document Modified: 2016-02-13 03:13:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop; request for comments.
DatesThe public workshop will be held on March 24, 2016, from 8:30 a.m. to 4:30 p.m.
ContactAnn 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, MD 20993-0002, [email protected]
FR Citation81 FR 7806 
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