Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 61875 

The collection of information under 

§ 801.437 does not constitute a 

‘‘collection of information’’ under the 

PRA. Rather, it is a ‘‘public disclosure 

of information originally supplied by 

the Federal Government to the recipient 

for the purpose of disclosure to the 

public’’ (5 CFR 1320.3(c)(2)). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex 

Condoms Classified Under 21 CFR 

884.5300 ....................................................... 5 1 5 12 60 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24445 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0114] 

Distinguishing Medical Device Recalls 

From Medical Device Enhancements; 

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 a guidance entitled, 

‘‘Distinguishing Medical Device Recalls 

From Medical Device Enhancements.’’ 

This guidance is intended to clarify 

when a potential change to a device is 

a medical device recall, distinguish 

those instances from product 

enhancements, and explain reporting 

requirements. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. 

ADDRESSES: 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 

single copies of the guidance document 

entitled, ‘‘Distinguishing Medical 

Device Recalls From Medical Device 

Enhancements’’ to the Office of the 

Center Director, Guidance and Policy 

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. 

Submit electronic comments on the 

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: 

Ronny Brown, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2654, Silver Spring, 

MD 20993–0002, 301–796–6163. 

I. Background 

Defects or performance failures of 

marketed medical devices can pose 

serious risks to public health. The recall 

process serves both to correct the device 

defects and to notify users of potential 

risks and steps to minimize the impact 

of device failure or improper function. 

The recall process establishes a 

mechanism for firms that produce and 

market medical devices to take timely 

action to correct or remove violative 

devices. 

When a firm’s recall process is 

operating effectively, the firm identifies 

a device defect or failure, determines 

that a recall is appropriate, and triggers 

the initiation of the recall process. 

However, firms may have trouble 

identifying whether a change to a device 

meets the definition of a recall, the 

appropriate scope of a recall, and when 

FDA should be notified of a recall. 

These issues can result in delays in 

notifying the public about unsafe 

medical devices. 

FDA also recognizes that continuous 

improvement activities, as part of an 

effective quality system, often have a 

favorable impact on medical device 

safety and are part of ongoing efforts to 

design and manufacture devices that 

meet the needs of the user and patient. 

When a new iteration of a device has 

improved design, for example, this does 

not necessarily mean that the prior 

version of the device should be recalled. 

Such changes may be appropriately 

characterized instead as product 

enhancements. In addition to 

determining whether a proposed change 

to a marketed device meets the 

definition of a device recall or a product 

enhancement, a firm must assess 

whether it is required to report the 

change to FDA. 

In the Federal Register of February 

22, 2013 (78 FR 12329), FDA announced 

the availability of the draft guidance 

document. Interested persons were 

invited to comment by May 23, 2013. 

Multiple comments were received with 

recommendations pertaining to three 

main areas: (1) Clarification of 

definitions; (2) requests for more 

examples; and (3) clarification of 

reporting obligations pertaining to 21 

CFR part 806. In response to these 

comments, FDA revised the guidance 

document to enhance clarity through 

the inclusion of multiple new examples. 

Some previously-included examples 

were deleted or reframed for improved 

clarity, and some content was removed 

since it did not enhance clarity and in 

some cases led to confusion. The 

guidance as revised provides more 

succinct information about the 

distinctions between medical device 

recalls and medical device 

enhancements and related reporting 

obligations. The guidance is organized 

in a question-and-answer format, 

providing responses to questions that 

FDA believes are helpful in properly 

identifying medical device recalls and 

applying reporting requirements. 

II. Significance of Guidance 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on the difference 

between a medical device recall and a 


tkelley on DSK3SPTVN1PROD with NOTICES
61876 Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 

medical device enhancement. 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 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. Persons 

unable to download an electronic copy 

of ‘‘Distinguishing Medical Device 

Recalls From Medical Device 

Enhancements,’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1819 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

The guidance refers to previously 

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 7, subpart C, have been 

approved under OMB control number 

0910–0249; 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; and 

the collections of information in 21 CFR 

part 810 have been approved under 

OMB control number 0910–0432. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). 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: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24446 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


tkelley on DSK3SPTVN1PROD with NOTICES