Document ID: FDA-2014-N-1496-0001
Agency: fda
Document Type: Notice
Title: Regulatory Science Considerations for Software Used in Diabetes
Management; Public Workshop; Request for Comments
Posted Date: 2014-10-15T04:00Z

[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61876-61877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24451]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1496]

Regulatory Science Considerations for Software Used in Diabetes 
Management; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Regulatory Science Considerations for 
Software Used in Diabetes Management.'' The goals of this public 
workshop are to foster greater stakeholder collaboration in the area of 
diabetes device interoperability and to seek input from the clinical 
community, academia, government, industry, and other stakeholders 
regarding usability considerations for appropriate information 
consumption (e.g., notifications, indicators, data, and displays) based 
on user skill and knowledge. The Agency also requests input regarding 
the technical considerations for insulin bolus calculator design and 
use.
    Date and Time: The public workshop will be held on November 13, 
2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Please arrive early to ensure time for parking and 
security screening. The public meeting will also be available to be 
viewed online via Webcast.
    Contact Persons: James Mullally, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5613, Silver Spring, MD 20993, 240-402-5021, FAX: 
301-847-8513, email: james.mullally@fda.hhs.gov; and Runa Musib, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5633, Silver Spring, MD 20993, 
301-796-7014, FAX: 301-847-8513, email: runa.musib@fda.hhs.gov.
    Registration: Registration is free and available on a first-come, 
first-served basis. You must register online by 4 p.m., November 6, 
2014. 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 a.m. If you need 
special accommodations due to a disability, please contact Susan 
Monahan, 301-796-5661, email: susan.monahan@fda.hhs.gov, no later than 
October 30, 2014.
    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 public workshop from the posted events list). Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. Those without 
Internet access should contact Susan Monahan to register (see 
registration contact person). 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. Persons interested in viewing the Webcast must 
register online by 4 p.m., November 6, 2014. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after November 6, 2014. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in 
this document, but FDA is not responsible for any subsequent changes to 
the Web

[[Page 61877]]

sites after this document publishes in the Federal Register.)
    Requests for Oral Presentations: This public workshop includes a 
public comment session. During online registration you may indicate if 
you wish to speak during the public comment 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. 
Following the close of registration, FDA will determine the amount of 
time allotted to each speaker and will select and notify participants 
by November 10, 2014. No commercial or promotional material will be 
permitted to be presented or distributed at the public workshop.
    Comments: FDA is holding this public workshop to obtain input on 
insulin bolus calculators. In order to permit the widest possible 
opportunity to obtain public comment, FDA is soliciting either 
electronic or written comments regarding the public workshop topics 
that pertain to insulin bolus calculators. The deadline for submitting 
comments related to this public workshop is December 11, 2014.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Please identify comments with the docket number found in 
brackets in the heading of this document. In addition, when responding 
to specific questions as outlined in section II of this document, 
please identify the question number you are addressing. 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.
    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 Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the 
posted events list), approximately 45 days after the workshop.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is seeking to foster greater stakeholder collaboration in the 
area of diabetes device interoperability. To that end, the Agency 
requests input from the clinical community, academia, government, 
industry, and other stakeholders regarding usability considerations for 
appropriate information consumption (e.g., notifications, indicators, 
data, and displays) based on user skill and knowledge. The Agency also 
requests input regarding the technical considerations for calculator 
design and use.
    The first topic of discussion is the interoperability between 
diabetes devices. The Agency recognizes that the diabetes community 
possesses an interest in patients having greater flexibility to pair 
device components, e.g., continuous glucose meters with insulin pumps 
from different manufacturers. Pairing would allow those devices to 
communicate with each other and enable patients to interact with a 
single interface platform. Achieving this goal would improve data 
tracking and access, thereby facilitating more productive patient 
interactions with their healthcare providers. In order to realize the 
objective of effective diabetes device interoperability, developers and 
manufacturers should discuss technical, safety, and regulatory 
challenges that lay before this goal. A forum that elicits opinions 
from physicians and patients regarding their desires and needs will 
help inform those discussions. FDA is committed to fostering a 
collaborative environment to promote these interactions.
    The second topic of discussion is insulin bolus calculators. These 
devices are intended to calculate insulin boluses for patients who 
manage their diabetes with insulin-intensive therapy. FDA currently 
regulates insulin bolus calculators as class II devices, often clearing 
them in combination with insulin pumps or blood glucose meters. Devices 
that calculate insulin boluses are increasingly available on the 
market, including those devices that use novel dosing algorithms and 
new user interface formats. Although these devices can benefit patient 
care, they could also jeopardize patient safety without proper 
regulation guarding against the serious health consequences of 
miscalculating insulin dosages. The Agency will host a public dialogue 
about insulin bolus calculators to help realize the aim of ensuring 
continued access to safe and effective technological innovations, 
regardless of interface format.
    The public workshop will include two sessions, one for each of the 
topics noted previously. Each session will include presentations from 
physicians, FDA, and other experts in the field. A panel discussion 
will follow the session addressing insulin bolus calculators, and the 
panel will address questions from the audience. In addition, Agency 
representatives will update the diabetes community on relevant FDA 
news.

II. Topics for Discussion at the Public Workshop

    Among other topics, the workshop will include discussion of the 
following questions.
    1. How can patients and providers be confident that the insulin 
bolus values obtained from the calculators are accurate and appropriate 
for their use?
    2. What information do patients and providers need about how a 
particular calculator works so that they may appropriately use the 
calculator for diabetes management?
    3. How can FDA foster both innovation and safety of insulin dose 
calculators intended for use by healthcare practitioners?
    4. How can FDA foster both innovation and safety of insulin dose 
calculators intended for use by patients?

    Dated: October 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24451 Filed 10-14-14; 8:45 am]
BILLING CODE 4164-01-P