Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability, 74195-74196 [2012-30033]

Download as PDF 74195 Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices for this collection. The commenter also provided comments that were not PRA- related and are beyond the scope of this document. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Meeting requests and information packages Number of responses per respondent Total annual responses Average burden per response (in hours) Total hours Meeting Requests Combining and sending meeting request letters for manufacturers, importers, and researchers .............................. 67 1 67 10 670 Meeting Information Packages Combining and submitting meeting information packages for manufacturers, importers, and researchers. ............... 67 1 67 18 1,206 Collection Totals ........................................................... ........................ ........................ ........................ ........................ 1,876 srobinson on DSK4SPTVN1PROD with 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA’s estimate of the number of respondents for meeting requests in table 1 of this document is based on the number of meeting requests to be received over the next three years. In year 1 of this collection, FDA estimates that 50 preapplication meetings will be requested. In year 2, FDA estimates that 100 meetings will be requested, especially as applications and reports for substantial equivalence, etc., are received and acted upon. Once the public knows more about submitting these applications in year 3 three, the request for meetings is expected to drop back to the year 1 one rate of 50 per year. Thus, FDA estimates the number of manufacturers, importers, researchers, and investigators who are expected to submit meeting requests in table 1 of this document to be 67 (50 year 1 requests + 100 year 2 requests + 50 year 3 requests divided by 3). The hours per response, which is the estimated number of hours that a respondent would spend preparing the information recommended by the guidance to be submitted with a meeting request, is estimated to be approximately 10 hours each, and the total burden hours are 670 hours (10 hours preparation/mailing times 67 average respondents per year). Based on FDA’s experience, the Agency expects it will take respondents this amount of time to prepare, gather, copy, and submit brief statements about the product and a description of the purpose and details of the meeting. FDA’s estimate of the number of respondents for compiling meeting information packages in table 1 of this document is based on 67 respondents each preparing copies of their information package and submitting them to FDA, for a total of 1,206 hours VerDate Mar<15>2010 16:21 Dec 12, 2012 Jkt 229001 annually. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package as recommended by the guidance, is estimated to be approximately 18 hours per information package. Based on FDA’s experience, the Agency expects that it will take respondents 1,206 hours of time (67 respondents times 18 hours) to gather, copy, and submit brief statements about the product, a description of the details of the anticipated meeting, and data and information that generally would already have been generated for the planned research and/or product development. The total number of burden hours for this collection of information is 1,876 hours (670 hours to prepare and submit meeting requests and 1,206 hours to prepare and submit information packages). Dated: December 7, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30057 Filed 12–12–12; 8:45 am] BILLING CODE 4160–01–P 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: PO 00000 Notice. Frm 00032 Fmt 4703 Sfmt 4703 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 SUMMARY: E:\FR\FM\13DEN1.SGM 13DEN1 74196 Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices srobinson on DSK4SPTVN1PROD with 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 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: 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, VerDate Mar<15>2010 16:21 Dec 12, 2012 Jkt 229001 and the utilization of human factors. This should result in a safe and easierto-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-thecounter 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from CBER at https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Design Considerations for Devices Intended for Home Use’’ from CDRH, 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 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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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 https:// 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 https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–1005] Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Safety Considerations for Product Design to Minimize Medication Errors.’’ The draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application (e.g., monograph) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. SUMMARY: E:\FR\FM\13DEN1.SGM 13DEN1

Agencies

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

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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:
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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov or from CBER
at https://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 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 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 https://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 https://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

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