80 FR 10125 - National Medical Device Postmarket Surveillance System Planning Board Report; Availability, Web Site Location and Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 37 (February 25, 2015)

Page Range		10125-10126
FR Document		2015-03886

The Food and Drug Administration (FDA) is announcing the availability of the report and Web site location where the Agency has posted the report entitled ``Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,'' developed by the National Medical Device Postmarket Surveillance System Planning Board. In addition, FDA has established a docket where stakeholders may provide comments.

Federal Register, Volume 80 Issue 37 (Wednesday, February 25, 2015)

[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10125-10126]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-03886]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0359]

National Medical Device Postmarket Surveillance System Planning
Board Report; Availability, Web Site Location and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the report and Web site location where the Agency has
posted the report entitled ``Strengthening Patient Care: Building an
Effective National Medical Device Surveillance System,'' developed by
the National Medical Device Postmarket Surveillance System Planning
Board. In addition, FDA has established a docket where stakeholders may
provide comments.

DATES: Submit either electronic or written comments by April 27, 2015.

ADDRESSES: Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

[[Page 10126]]

FOR FURTHER INFORMATION CONTACT: Thomas P. Gross, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2316, Silver Spring, MD 20993-0002, 301-
796-5700, email: Thomas.Gross@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA's Center for Devices and Radiological Health is responsible for
protecting the public health by assuring the safety and effectiveness
of medical devices. A key part of this mission is to monitor medical
devices for continued safety and effectiveness after they are in use
and to help the public get the accurate, science-based information they
need to improve their health.
In September 2012, the FDA published a report, ``Strengthening Our
National System for Medical Device Postmarket Surveillance,'' that
proposed a strategy for improving the current system for monitoring
medical device safety and effectiveness. In April 2013, the FDA issued
an update to the September 2012 report that incorporated public input
received and described the next steps towards fulfilling the vision for
building a national postmarket surveillance system. These reports can
be found at FDA's Web site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.
One of these next steps consisted of establishing a
multistakeholder planning board to identify the governance structure,
practices, policies, procedures, methodological approaches, and
business model(s) necessary to facilitate the creation of a
sustainable, integrated medical device postmarket surveillance system
that leverages and complements existing and ongoing efforts. Under a
cooperative agreement with the FDA, the Engelberg Center for Health
Care Reform at the Brookings Institution convened the National Medical
Device Postmarket Surveillance Planning Board (the Planning Board) in
2014. The Planning Board membership included representatives from a
broad array of stakeholder groups and areas of expertise including
patients, provider organizations, hospitals, health plans, industry,
and government agencies, as well as methodologists and academic
researchers.
The Planning Board was tasked with developing a set of long-term
principles and priorities for a National Postmarket Surveillance
System. The task included identifying potential governance and business
models that address legal and privacy considerations, system financing
and stability, mechanisms to support the appropriate use of data, and
policies to ensure system transparency. The Planning Board was also
asked to provide recommendations about how to leverage the system to
meet the needs of other medical device stakeholders and groups seeking
to develop better evidence (http://www.brookings.edu/about/centers/health/call-for-nominations and https://dcri.org/events/past-meetings/MDEpiNet-nominations).
This notice announces the availability and Web site location of the
Planning Board's report entitled ``Strengthening Patient Care: Building
an Effective National Medical Device Surveillance System.'' FDA invites
interested persons to submit comments on this report. We have
established a docket where comments may be submitted (see ADDRESSES).
We believe this docket is an important tool for receiving feedback on
this report from interested parties and for sharing this information
with the public. The report ``Strengthening Patient Care: Building an
Effective National Medical Device Surveillance System'' can be found at
FDA's Web site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.

II. Request for Comments

Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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. 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.

Dated: February 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03886 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10125

Streaming Webcast of the Public Rockville, MD 20857. A link to the 3. Unique benefits of RAS devices
Workshop: This public workshop will transcripts will also be available versus traditional surgical procedures.
also be Webcast. Persons interested in approximately 45 days after the public 4. Scientific and technical
viewing the Webcast must register workshop on the Internet at http:// considerations for third-party
online by Friday, July 17, 2015. Early www.fda.gov/MedicalDevices/ manufacturers seeking to claim that
registration is recommended because NewsEvents/WorkshopsConferences/ their surgical instruments can be used
Webcast connections are limited. default.htm. (Select this public with legally marketed RAS devices.
Organizations are requested to register workshop from the posted events list). 5. Design, administration, and
all participants, but to view using one SUPPLEMENTARY INFORMATION: certification of training programs and
connection per location. Webcast FDA’s role in this process.
participants will be sent technical I. Background 6. The future landscape of RAS and
system requirements after registration RAS devices, also known as robotic surgery devices.
and will be sent connection access computer-assisted surgical devices, are 7. Considerations regarding
information after July 20, 2015. If you used by trained physicians in an appropriate selection of preclinical
have never attended a Connect Pro operating room environment for (bench and animal) test methods and
event before, test your connection at laparoscopic surgical procedures in patient-centered outcome metrics in
https://collaboration.fda.gov/common/ general surgery, cardiac, colorectal, clinical use for different stages of device
help/en/support/meeting_test.htm. To gynecologic, head and neck, thoracic, development.
get a quick overview of the Connect Pro and urologic surgical procedures. These These topics will be presented by
program, visit http://www.adobe.com/ medical devices enable the surgeon to experts in the associated area, followed
go/connectpro_overview. (FDA has use computer, software, and robotic by more in-depth discussions and Q&A
verified the Web site addresses in this technologies to control and move from all participants.
document, but FDA is not responsible surgical instruments through the mouth Dated: February 19, 2015.
for any subsequent changes to the Web or through one or more small incisions Leslie Kux,
sites after this document publishes in in the patient’s body for a variety of Associate Commissioner for Policy.
the Federal Register.) surgical procedures. Some common
Comments: FDA is holding this public [FR Doc. 2015–03769 Filed 2–24–15; 8:45 am]
procedures that may involve RAS
workshop to obtain information on the BILLING CODE 4164–01–P
devices include gallbladder, uterus, or
specific topics outlined in section II. In
prostate removal.
order to permit the widest possible
opportunity to obtain public comment, As discussed further in section II, DEPARTMENT OF HEALTH AND
FDA is soliciting either electronic or there are several clinical and scientific HUMAN SERVICES
written comment on all aspects of the challenges associated with regulation of
public workshop topics. The deadline RAS devices, such as appropriate Food and Drug Administration
for submitting comments related to this nonclinical and clinical evaluation of [Docket No. FDA–2012–N–0359]
public workshop is August 26, 2015. RAS devices, use of third-party surgical
Regardless of attendance at the public instruments with legally marketed RAS National Medical Device Postmarket
workshop, interested persons may devices, and clinical training programs. Surveillance System Planning Board
submit either electronic comments to This workshop seeks to involve industry Report; Availability, Web Site Location
http://www.regulations.gov or written and academia in addressing these and Request for Comments
comments to the Division of Dockets challenges in the development of RAS
devices to ensure that there is a AGENCY: Food and Drug Administration,
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm. reasonable assurance of safety and HHS.
1061, Rockville, MD 20852. It is only effectiveness for RAS devices while ACTION: Notice; request for comments.
necessary to send one set of comments. promoting innovation in a rapidly-
developing field. By bringing together SUMMARY: The Food and Drug
Please identify comment with the
relevant stakeholders including Administration (FDA) is announcing the
docket number found in brackets in the
scientists, patient advocates, clinicians, availability of the report and Web site
heading of this document. In addition,
researchers, industry representatives, location where the Agency has posted
when responding to specific topics as
and regulators, we hope to facilitate the the report entitled ‘‘Strengthening
outlined in section II, please identify the
improvement of this evolving product Patient Care: Building an Effective
topic(s) you are addressing. Received
area. National Medical Device Surveillance
comments may be seen in the Division
System,’’ developed by the National
of Dockets Management between 9 a.m. II. Topics for Discussion at the Public Medical Device Postmarket Surveillance
and 4 p.m., Monday through Friday, and Workshop System Planning Board. In addition,
will be posted to the docket at http://
Topics to be discussed at the public FDA has established a docket where
www.regulations.gov.
Transcripts: Please be advised that as workshop include, but are not limited stakeholders may provide comments.
soon as a transcript is available, it will to, the following: DATES: Submit either electronic or
be accessible at http:// 1. The current landscape of RAS written comments by April 27, 2015.
www.regulations.gov. It may be viewed devices and the respective Offices, ADDRESSES: Submit electronic
at the Division of Dockets Management Divisions, and Branches within FDA comments on this document to http://
asabaliauskas on DSK5VPTVN1PROD with NOTICES

(see Comments). A transcript will also involved in the review of pre- and www.regulations.gov. Submit written
be available in either hardcopy or on postmarket data associated with these comments to the Division of Dockets
CD–ROM, after submission of a devices. Management (HFA–305), Food and Drug
Freedom of Information request. Written 2. Challenges, needs, and benefit/risk Administration, 5630 Fishers Lane, rm.
requests are to be sent to the Division profiles for indications in various 1061, Rockville, MD 20852. Identify
of Freedom of Information (ELEM– surgical areas; e.g. cardio/thoracic, comments with the docket number
1029), Food and Drug Administration, gynecological, otolaryngological, found in brackets in the heading of this
12420 Parklawn Dr., Element Bldg., urological, general. document.

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Document Created: 2015-12-18 13:09:23
Document Modified: 2015-12-18 13:09:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; request for comments.
Dates		Submit either electronic or written comments by April 27, 2015.
Contact		Thomas P. Gross, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2316, Silver Spring, MD 20993-0002, 301- 796-5700, email: [email protected]
FR Citation		80 FR 10125

80 FR 10125 - National Medical Device Postmarket Surveillance System Planning Board Report; Availability, Web Site Location and Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 37 (February 25, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration