5762 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm or at 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of the draft guidance document entitled 

‘‘Enforcement Policy on National Health 

Related Item Code and National Drug 

Code Numbers Assigned to Devices’’ 

may send an email request to CDRHGuidance@fda.hhs.gov or to 

ocod@fda.hhs.gov, or by calling 1–800– 

835–4709 or 240–402–7800, to receive 

an electronic copy of the document. 

Please use the document number 

GUD1500044 to identify the guidance 

you are requesting. 

V. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information described 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 have been approved under 

OMB control number 0910–0485, and 

the collections of information in 21 CFR 

part 830 have been approved under 

OMB control number 0910–0720. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01892 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0469] 

Applying Human Factors and Usability 

Engineering to Medical Devices; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Applying Human Factors and Usability 

Engineering to Medical Devices.’’ FDA 

has developed this guidance document 

to assist industry in following 

appropriate human factors and usability 

engineering processes to maximize the 

likelihood that new medical devices 

will be safe and effective for the 

intended users, uses, and use 

environments. The recommendations in 

this guidance document are intended to 

support manufacturers in improving the 

design of medical devices to minimize 

potential use errors and resulting harm. 

FDA believes that these 

recommendations will enable 

manufacturers to assess and reduce risks 

associated with medical device use. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2011–D–0469 for ‘‘Applying Human 

Factors and Usability Engineering to 

Medical Devices.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

An electronic copy of the guidance 

document is available for download 

from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Applying Human 

Factors and Usability Engineering to 

Medical Devices’’ to the Office of the 

Center Director, Guidance and Policy 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 5763 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Hoste, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2531, Silver Spring, 

MD 20993–0002, 240–402–3747 or 

Shannon.hoste@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 in the development of 

medical devices include the 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 should be 

included in 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 avoiding potential device 

recalls. 

In the Federal Register of June 22, 

2011 (76 FR 36543), FDA announced the 

availability of the draft guidance 

document. Interested persons were 

invited to comment by September 19, 

2011. FDA received over 600 comments, 

which were generally supportive of the 

draft guidance document, but requested 

clarification in a number of areas. The 

most frequent types of comments 

requested revisions to the language or 

structure of the document, or 

clarification on risk mitigation and 

human factors testing methods, user 

populations for testing, training of test 

participants, determining the 

appropriate sample size in human 

factors testing, reporting of testing 

results in premarket submissions, and 

collecting human factors data as part of 

a clinical study. In response to these 

comments, FDA revised the guidance 

document to clarify the points identified 

and restructured the information for 

better readability and comprehension. 

This guidance supersedes the guidance 

entitled ‘‘Medical Device Use-Safety: 

Incorporating Human Factors 

Engineering into Risk Management’’ 

dated July 18, 2000, which will be 

withdrawn. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Applying Human 

Factors and Usability Engineering to 

Medical Devices.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Applying Human Factors and 

Usability Engineering to Medical 

Devices’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 1747 

to identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations and guidance. 

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 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, 

subparts A through E 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; the 

collections of information in 21 CFR 

parts 801 and 809 are approved under 

OMB control number 0910–0485; and 

the collections of information in the 

guidance document entitled ‘‘Requests 

for Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ are 

approved under OMB control number 

0910–0756. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01887 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0194] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Biosimilar User Fee Cover Sheet; Form 

FDA 3792 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Biosimilar User Fee Cover Sheet; Form 

FDA 3792’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On June 

23, 2015, the Agency submitted a 

proposed collection of information 

entitled ‘‘Biosimilar User Fee Cover 

Sheet; Form FDA 3792’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0718. The approval expires on 

December 31, 2018. A copy of the 

supporting statement for this 

mstockstill on DSK4VPTVN1PROD with NOTICES