[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74195-74196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1161]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Design Considerations for Devices Intended for Home Use; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Design Considerations for 
Devices Intended for Home Use.'' This document is intended to assist 
manufacturers in designing and developing home use medical devices that 
comply with applicable standards of safety and effectiveness and other 
regulatory requirements. Home use devices are associated with unique 
risks created by the interactions among the user (often a layperson), 
the use environment, and the device. This document identifies several 
factors that manufacturers should consider, especially during device 
design and development, and provides recommendations for reducing or 
minimizing these unique risks. This draft guidance is not final nor is 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 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 13, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Design Considerations for Devices Intended 
for Home Use'' to the Division of Small Manufacturers, International, 
and Consumer Assistance, Center for Devices and Radiological Health 
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 4613, Silver Spring, MD 20993-0002; or to the Office of 
Communication, Outreach and Development (HFM-40), Center for

[[Page 74196]]

Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852-1448. 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  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.

FOR FURTHER INFORMATION CONTACT: 
    For information concerning the guidance as it relates to devices 
regulated by CDRH: Mary Brady, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5426, Silver Spring, MD 20993-0002, 301-796-6089.
    For information concerning the guidance as it relates to devices 
regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-6210.

I. Background

    For a variety of reasons, use of devices outside professional 
healthcare facilities or clinical laboratories is on the rise. First, 
the U.S. population is aging, and the elderly are more likely to live 
with chronic diseases that require daily medical care at home. Second, 
due to medical advancements, many individuals with chronic diseases are 
living longer, but are dependent on home medical care. Finally, an 
increasing focus on reducing healthcare costs for patients of all ages 
has spurred the growth of the home health care market. Integral to the 
home health care market are home use devices. Although home use devices 
provide significant benefits to patients and families, including 
quality of life improvements and cost savings, home use devices are 
also associated with unique risks. Reducing or minimizing the risks 
posed by home use devices can greatly improve the public health.
    This draft guidance provides recommendations for designing and 
developing medical devices intended for home use through considerations 
involving the physical environment, the user, the device or system, the 
labeling, and the utilization of human factors. This should result in a 
safe and easier-to-use device, minimize use error, and reduce the 
likelihood that adverse events will occur. The recommendations in the 
guidance apply to both prescription and over-the-counter medical 
devices that are intended for home use.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the total 
product life cycle for devices intended for home use. 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 for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Design Considerations for Devices Intended for Home Use'' from CDRH, 
you may either send an email request to [email protected] 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 1750 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 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 801 and 21 CFR 809.10 have 
been approved under OMB control number 0910-0485; the collections of 
information in 21 CFR part 803 have been approved under OMB control 
number 0910-0437; the collections of information in 21 CFR part 807, 
subpart E have been approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231; the collections of information in 21 CFR 
part 820 have been approved under OMB control number 0910-0073; and the 
collections of information in Form FDA 3500A have been approved under 
OMB control number 0910-0291.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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: December 5, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30033 Filed 12-12-12; 8:45 am]
BILLING CODE 4160-01-P