[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Pages 73407-73410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25735]



Food and Drug Administration

[Docket No. FDA-2016-N-1380]

The Role of Hospitals in Modernizing Evidence Generation for 
Device Evaluation: Harnessing the Digital Revolution for Surveillance; 
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``The Role of Hospitals in 
Modernizing Evidence Generation for Device Evaluation: Harnessing the 
Digital Revolution for Surveillance.'' Hospitals play a critical role 
in the development

[[Page 73408]]

of these national capabilities, leading to more robust evidence 
generation. Recently, the role of hospital reporting of device-related 
adverse events in device surveillance and, more generally, device 
evaluation, has garnered increased scrutiny. This public workshop will 
further explore the critical role of hospitals in the evolution of 
device surveillance and in creating more robust surveillance 

DATES: The public workshop will be held on December 5, 2016, 8:30 a.m. 
to 5 p.m. ET. Submit either electronic or written comments on the 
public workshop by January 6, 2017.

ADDRESSES: The public workshop will be held at Fishers Lane Conference 
Center, Terrace Level, 5635 Fishers Lane, Rockville, MD 20852. Parking 
is available for this public meeting at $7 per day (cash only). 
Alternatively, the location is accessible by metro via the Twinbrook 
metro stop (Red Line). When you leave the Metro station, make a right 
turn towards the east side of the parking lot. Proceed to the north 
east corner of the parking lot and leave through the pedestrian gate. 
When you exit the station you will be at the corner of Fishers Lane and 
Twinbrook Parkway. Cross the street and proceed down Fishers Lane to 
5635 Fishers Lane. Entering through the main front entrance on Fishers 
Lane, you will need to take an elevator down to the Terrace Level. 
Follow the short hallway towards the elevators and the Conference 
Center glass doors are straight ahead near the elevators.
    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-1380 for ``The Role of Hospitals in Modernizing Evidence 
Generation for Device Evaluation: Harnessing the Digital Revolution for 
Surveillance.'' 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 
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: Jill Marion, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3110, Silver Spring, MD 20993, 301-796-6128, 
[email protected].


I. Background

    In 2012, FDA issued a report, ``Strengthening Our National System 
for Medical Device Postmarket Surveillance,'' \1\ that described 
limitations in current authorities and approaches to medical device 
postmarket surveillance and proposed a strategy for a national medical 
device postmarket surveillance system. The system would leverage real-
world data--data developed through routine clinical practice--captured 
in electronic health information (such as device registries, electronic 
health records, and payer claims forms) that incorporated unique device 
identifiers to quickly identify poorly performing devices, accurately 
characterize and disseminate information about real-world device 
performance, including the clinical benefits and risks of marketed 
devices, and efficiently generate data to support premarket clearance 
or approval of new devices and new uses of currently marketed devices. 
Following extensive public input, FDA issued an update in 2013 \2\ that 
outlined concrete steps the Agency would take to promote more efficient 
and robust national system capabilities. Two critical steps were the 
creation of a Planning Board and a Medical Device Registry Task Force. 
The Brookings Institution, under commission by FDA, convened a 
multistakeholder Planning Board. In February 2015, the Planning Board 
issued a report, ``Strengthening Patient

[[Page 73409]]

Care: Building a National Postmarket Medical Device Surveillance 
System,'' \3\ that sets out the key steps towards development of a 
national system, including its governance, operations, and 

    \1\ http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM301924.pdf.
    \2\ http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf.
    \3\ http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM435112.pdf.

    The system was renamed an ``evaluation system'' to reflect the 
broad evidence needs of stakeholders with the August 2015 release of 
the report, ``Recommendations for a National Medical Device Evaluation 
System: Strategically Coordinated Registry Networks to Bridge the 
Clinical Care and Research,'' issued by the multistakeholder Task 
Force, under the auspices of the Medical Device Epidemiology Network 
(MDEpiNet).\4\ In 2016, the Planning Board, convened by the Duke-
Margolis Center for Health Policy, published ``Better Evidence on 
Medical Devices: A Coordinating Center for a 21st Century National 
Medical Device Evaluation System.'' \5\ This document further clarifies 
the expectations, roles, and responsibilities of the coordinating 
center described in the Planning Board's earlier 2015 report. This 
additional detail provides insight into the expected business practices 
of an independent, transparent coordinating center that would guide the 
future development and implementation of the national evaluation system 
now referred to as the National Evaluation System for Health Technology 
(NEST). The Planning Board's most recent and last report titled, The 
National Evaluation System for health Technology (NEST): Priorities for 
Effective Early Implementation, was issued in September 2016. The 
report provides recommendations on organizational governance, 
development of NEST resources, and development/demonstration project 
areas to help begin building resources for NEST while demonstrating 
value to stakeholders.\6\ FDA is in the process of implementing the 
Task Force's and Planning Board's recommendations including 
establishment of a Coordinating Center. FDA issued a grant in September 
to the Medical Device Innovation Consortium to establish the center.

    \4\ http://mdepinet.org/.
    \5\ https://healthpolicy.duke.edu/files/2016/03/med-device-report-web.pdf.
    \6\ http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.

    The importance and challenges of hospital surveillance efforts have 
long been recognized. In 1997, Congress passed the Food and Drug 
Administration Modernization Act (Pub. L. 105-115), which amended 
section 519(b) of the Food, Drug and Cosmetic Act (21 U.S.C. 360i(b)). 
This amendment legislated the replacement of universal user facility 
reporting by an alternative system that is limited to a ``. . . subset 
of user facilities that constitutes a representative profile of user 
reports'' for device related deaths and serious injuries. In response, 
FDA developed The Medical Product Safety Network (MedSun).\7\ Currently 
there are approximately 300 hospitals nationwide that are active, 
voluntary partners with FDA in the assessment and reporting of device-
related events. The value of and challenges with the MedSun reporting 
program will be discussed at the workshop, including the limitations of 
passive reporting as a sole source of timely identification for the 
investigation and resolution of device safety issues. At this time, the 
digital revolution offers new opportunities to leverage information 
collected during routine clinical care and to build a robust national 
evaluation infrastructure. Therefore, the Agency believes it is an 
opportune time to revisit the role of hospitals in device surveillance, 
taking into account the limitations and challenges of traditional 
surveillance tools and the growing availability of new tools, 
methodologies, and electronic data sources. This public workshop is 
intended to bring together many medical device stakeholders from 
hospitals including clinicians, epidemiologists, healthcare risk 
managers, IT system managers, healthcare technology management 
professionals, clinical researchers, and others involved in 
surveillance efforts to discuss current hospital-based surveillance 
efforts, the role of hospitals in evidence generation and future 
opportunities for hospital-based surveillance, the importance of using 
unique device identification (UDI) to aid future development of 
surveillance efforts and healthcare delivery, and the partnership 
needed to build the future of surveillance into the infrastructure for 
NEST. Building the national evaluation system will bring with it 
changes that may support efforts in hospitals to address broader issues 
of improved quality of care and efficiencies.

    \7\ http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/.

II. Topics for Discussion at the Public Workshop

    This workshop is intended to foster a dialogue about the value of, 
costs of, and challenges with current hospital-based reporting and 
surveillance, what the role of hospitals should be and reasonably could 
be in the evolution of device surveillance and in creating more robust 
surveillance capabilities in the developing national evaluation system, 
and how that should impact current hospital reporting requirements and 
future voluntary opportunities to best meet the needs of patients in 
receiving and hospitals in providing quality care. Topics for 
discussion at the public workshop include:
     An overview of the role of hospitals and potential 
benefits from a national evaluation system.The recent reports of the 
Planning Board and the work in transitioning to establishing a 
Coordinating Center to support development of the national system.
     The role of hospitals in evidence generation and how this 
fits into the national system;
     Current hospital-based surveillance efforts including 
participation in registries, patient safety organizations, electronic 
health records-based surveillance projects, and other surveillance 
     A review of the role of hospitals in medical device 
reporting activities as outlined in the Safe Medical Devices Act (Pub. 
L. 101-629) and current challenges hospitals face in complying with 
these requirements. An assessment of the current value of reporting 
from user facilities and identification of opportunities for process 
     An exploration of FDA's MedSun, a user facility reporting 
program introduced in 2002 which partners with a subset of user 
facilities in the United States to identify and report medical device 
events including mandatory events under the Safe Medical Devices Act 
and voluntary events.
     Future surveillance opportunities for hospitals in the 
national system, including use of non-traditional sources of hospital 
data and capabilities.
     A review of the potential benefits to hospitals of the 
national system and Unique Device Identification implementation to 
modernize hospital surveillance. Additional benefits to hospitals 
include improvement of supply chain management, efficiency of recalls, 
efficiency of medical device purchasing, and quality of care.
     A discussion of how all stakeholders can work together to 
improve hospital-based medical device surveillance and determine the 
role and value of evidence generation as it is integrated into the 
developing national evaluation system.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending

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this public workshop must register online by November 28, 2016. 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 public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Office of Communications and Education, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-
5661, FAX: 301-847-8142, [email protected] no later than 
November 21, 2016.
    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, and affiliation, address, email, and telephone 
number. Those without Internet access should contact Susan Monahan to 
register (see special accommodations contact). 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. The Webcast link will be available on the registration 
Web page after November 28, 2016. Organizations are requested to view 
using one connection per location.
    Requests for Oral Presentations: This public workshop includes a 
public comment session and topic-focused sessions. During online 
registration you may indicate if you wish to present during a public 
comment session or participate in a specific session, and which topics 
you wish to address. FDA has included general topics in this document. 
FDA will do its best to accommodate requests to make public comments. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and request time for a 
joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. Following the close of 
registration, FDA will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify participants by November 29, 2016. All 
requests to make oral presentations must be received by November 15, 
2016. If selected for presentation, any presentation materials must be 
emailed to Jill Marion (see FOR FURTHER INFORMATION CONTACT) no later 
than December 2, 2016. No commercial or promotional material will be 
permitted to be presented or distributed at the public workshop.
    FDA is holding this public workshop to obtain information on the 
role of hospitals in evidence generation and surveillance. In order to 
permit the widest possible opportunity to obtain public comment, FDA is 
soliciting either electronic or written comments on all aspects of the 
public workshop topics. The deadline for submitting comments related to 
this public workshop is January 6, 2017.
    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 ADDRESSES). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov. A link to the transcript 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).

    Dated: October 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25735 Filed 10-24-16; 8:45 am]