Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability, 36543-36544 [2011-15570]
Download as PDF
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
Approval (PMA) Applications for Low
Glucose Suspend (LGS) Device
Systems,’’ you may either send an email request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1748 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently
approved collections of information
found in FDA regulations and guidance
documents. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
parts 801 and 809 are currently
approved under OMB control number
0910–0485, the collections of
information in 21 CFR part 812 are
currently approved under OMB control
number 0910–0078, and the collections
of information in 21 CFR part 814 are
currently approved under OMB control
number 0910–0231.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
Dated: June 16, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–15541 Filed 6–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2011–D–0469]
Draft Guidance for Industry and Food
and Drug Administration Staff:
Applying Human Factors and Usability
Engineering To Optimize Medical
Device Design; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
16:40 Jun 21, 2011
Jkt 223001
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: Applying Human
Factors and Usability Engineering to
Optimize Medical Device Design.’’ The
recommendations in this guidance are
intended to improve the safety and
effectiveness of devices and reduce use
error. This draft guidance is not final;
nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see
§ 10.115(g)(5) (21 CFR 10.115(g)(5))), to
ensure that the Agency considers your
comment on this draft guidance before
it begins work on the final version of the
guidance, submit electronic or written
comments on the draft guidance by
September 19, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: Applying Human
Factors and Usability Engineering to
Optimize Medical Device Design’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 301–
847–8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
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.
FOR FURTHER INFORMATION CONTACT:
Molly Story, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2533, Silver Spring,
MD 20993–0002, 301–796–1456, e-mail:
molly.story@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
To understand use-related hazards, it
is necessary to have an accurate and
complete understanding of how a device
will be used. Understanding and
optimizing how people interact with
technology is the subject of human
factors engineering (HFE) and usability
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
36543
engineering (UE). HFE/UE
considerations that are important to the
development of medical devices include
three major components of the deviceuser system: (1) Device users, (2) device
use environments, and (3) device user
interfaces.
For safety-critical technologies such
as medical devices, the process of
eliminating or reducing design-related
use problems that contribute to or cause
unsafe or ineffective medical treatment
is part of a process for controlling
overall risk. For devices where harm
could result from ‘‘use errors,’’ the
dynamics of user interaction are safetyrelated and should be components of
risk analysis and risk management. By
incorporating these considerations into
the device development process,
manufacturers can reduce the overall
risk level posed by their devices, thus
decreasing adverse events associated
with the device, and avoid potential
device recalls.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This draft guidance, when finalized,
will represent the Agency’s current
thinking on human factors engineering
for medical devices. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability is
available for all CDRH guidance
documents at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
default.htm. Guidance documents are
also available at https://
www.regulations.gov. To receive ‘‘Draft
Guidance for Industry and Food and
Drug Administration Staff: Applying
Human Factors and Usability
Engineering to Optimize Medical Device
Design.’’ you may either send an e-mail
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1757 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently
approved collections of information
found in FDA regulations. These
E:\FR\FM\22JNN1.SGM
22JNN1
36544
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 820 are approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 812 are approved under OMB
control number 0910–0078; the
collections of information in 21 CFR
part 807, subpart E are approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 814, subpart B are approved under
OMB control number 0910–0231; the
collections of information in 21 CFR
part 814, subpart H are approved under
OMB control number 0910–0332; and
the collections of information in 21 CFR
part 801 are approved under OMB
control number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
Dated: June 17, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–15570 Filed 6–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0443]
Scientific Evaluation of Modified Risk
Tobacco Product Applications; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
The Food and Drug Administration
(FDA), Center for Tobacco Products is
announcing a public workshop to obtain
input on specific issues associated with
the scientific evaluation of modified risk
tobacco product (MRTP) applications.
The Family Smoking Prevention and
Tobacco Control Act (the Tobacco
Control Act) establishes a requirement
VerDate Mar<15>2010
16:40 Jun 21, 2011
Jkt 223001
for persons to obtain an order from FDA
before they can introduce or deliver for
introduction into interstate commerce
MRTPs and outlines the requirements
that must be met before FDA will issue
such an order. The Tobacco Control Act
also directs FDA to get input from
appropriate scientific and medical
experts on the design and conduct of
studies and surveillance required for
assessment and ongoing review of
MRTP applications. The purpose of the
public workshop is to create a forum for
appropriate scientific and medical
experts and other interested
stakeholders to provide input on these
topics. FDA will take the information it
obtains from the public workshop into
account as it determines how best to
implement the MRTPs provisions of the
Tobacco Control Act. FDA is also
opening a public docket to receive
comments on these topics.
DATES: Dates and Times: The public
workshop will be held on August 25,
2011, from 8:30 a.m. to 5:30 p.m., and
on August 26, 2011, from 8:30 a.m. to
4 p.m. Individuals who wish to make a
presentation at the public workshop
must register by close of business on
August 3, 2011. Submit either electronic
or written comments to the docket by
September 23, 2011.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AboutFDA/WorkingatFDA/Buildingsand
Facilities/WhiteOakCampus
Information/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Contact Person: Anuja Patel, Office of
Science, Center for Tobacco Products,
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
1–877–287–1373 (choose option 4),
FAX: 240–276–3761, e-mail:
workshop.CTPOS@fda.hhs.gov.
Registration to Attend the Workshop
and Requests for Oral Presentation: If
you wish to attend the workshop or
make an oral presentation at the
workshop, please e-mail your
registration to
workshop.CTPOS@fda.hhs.gov by close
of business on August 3, 2011. Those
without e-mail access may register by
contacting Anuja Patel (see Contact
Person). Please provide contact
information for each attendee, including
name, title, affiliation, address, e-mail
address, and telephone number.
Registration is free and will be on a first-
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
come-first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization as well as the total number
of participants based on space
limitations. Registrants will receive
confirmation once they have been
accepted for the workshop. Onsite
registration on the day of the workshop
will be based on space availability. If
registration reaches maximum capacity,
FDA will post a notice closing
registration for the workshop at https://
www.fda.gov/TobaccoProducts/
default.htm.
An open comment session will be
held during the public workshop on
August 25, 2011, from 11 a.m. to
12:30 p.m., during which comments
from the public will be accepted. If you
would like to make an oral presentation
during the open comment session, you
must indicate this at the time of
registration. FDA has included
questions for comment in section II of
this document. You should identify the
question number(s) you will address in
your presentation and the approximate
time requested for your presentation.
FDA will do its best to accommodate
requests to speak. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations and request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin. Persons registered to make a
formal presentation must check in at the
registration table by 10 a.m. on August
25, 2011. In addition, we strongly
encourage submitting comments to the
docket (see Comments).
If you need special accommodations
because of a disability, please contact
Anuja Patel (see Contact Person) at least
7 days before the workshop.
Comments: Regardless of attendance
at the public workshop, interested
persons may submit comments on any
questions for comment in section II of
this document by September 23, 2011.
Submit electronic comments to https://
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. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed 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.
E:\FR\FM\22JNN1.SGM
22JNN1
Agencies
[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36543-36544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15570]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0469]
Draft Guidance for Industry and Food and Drug Administration
Staff: Applying Human Factors and Usability Engineering To Optimize
Medical Device Design; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance document entitled ``Draft Guidance
for Industry and Food and Drug Administration Staff: Applying Human
Factors and Usability Engineering to Optimize Medical Device Design.''
The recommendations in this guidance are intended to improve the safety
and effectiveness of devices and reduce use error. This draft guidance
is not final; nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))), to ensure that the Agency
considers your comment on this draft guidance before it begins work on
the final version of the guidance, submit electronic or written
comments on the draft guidance by September 19, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and Food and
Drug Administration Staff: Applying Human Factors and Usability
Engineering to Optimize Medical Device Design'' to the Division of
Small Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the draft guidance to https://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.
FOR FURTHER INFORMATION CONTACT: Molly Story, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2533, Silver Spring, MD 20993-0002, 301-796-1456,
e-mail: molly.story@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
To understand use-related hazards, it is necessary to have an
accurate and complete understanding of how a device will be used.
Understanding and optimizing how people interact with technology is the
subject of human factors engineering (HFE) and usability engineering
(UE). HFE/UE considerations that are important to the development of
medical devices include three major components of the device-user
system: (1) Device users, (2) device use environments, and (3) device
user interfaces.
For safety-critical technologies such as medical devices, the
process of eliminating or reducing design-related use problems that
contribute to or cause unsafe or ineffective medical treatment is part
of a process for controlling overall risk. For devices where harm could
result from ``use errors,'' the dynamics of user interaction are
safety-related and should be components of risk analysis and risk
management. By incorporating these considerations into the device
development process, manufacturers can reduce the overall risk level
posed by their devices, thus decreasing adverse events associated with
the device, and avoid potential device recalls.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
when finalized, will represent the Agency's current thinking on human
factors engineering for medical devices. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability is available for all CDRH
guidance documents at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. To receive
``Draft Guidance for Industry and Food and Drug Administration Staff:
Applying Human Factors and Usability Engineering to Optimize Medical
Device Design.'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number 1757 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently approved collections of
information found in FDA regulations. These
[[Page 36544]]
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
820 are approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 812 are approved under OMB control number
0910-0078; the collections of information in 21 CFR part 807, subpart E
are approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B are approved under OMB
control number 0910-0231; the collections of information in 21 CFR part
814, subpart H are approved under OMB control number 0910-0332; and the
collections of information in 21 CFR part 801 are approved under OMB
control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
Dated: June 17, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-15570 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P