71434 Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0194] 

Infusion Pumps Total Product Life 

Cycle; Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: Food and Drug 

Administration (FDA) is announcing the 

availability of the final guidance 

entitled, ‘‘Infusion Pumps Total Product 

Life Cycle; Guidance for Industry and 

FDA Staff.’’ The recommendations in 

this guidance are intended to improve 

the safety and effectiveness of these 

devices. This guidance also describes 

considerations in preparing premarket 

submissions for infusion pumps and 

identifies device features that 

manufacturers should address 

throughout the total product life cycle. 

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: 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 ‘‘Infusion Pumps 

Total Product Life Cycle; Guidance for 

Industry and FDA Staff’’ 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: 

Alan Stevens, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2561, Silver Spring, 

MD 20993–0002, 301–796–6294. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA has evaluated a broad spectrum 

of infusion pumps across manufacturers 

and has encountered common problems 

with device software, human factors, 

reliability, and manufacturing. Based on 

an evaluation of reported adverse events 

and recalls, FDA believes that many 

injuries and adverse events may be 

avoided by improving the design 

verification and validation processes for 

infusion pump devices. 

The most frequently reported infusion 

pump device problems are: Software 

error messages, human factors (which 

include, but are not limited to, use 

error), broken components, battery 

failure, alarm failure, over-infusion, and 

under-infusion. Subsequent analyses 

revealed that many of these design 

problems could be corrected during the 

design validation and verification 

processes. 

The Agency believes that this 

guidance provides recommendations 

that will help mitigate observed risk and 

reduce potential risk associated with 

infusion pumps. One method of 

improving the safety of infusion pumps 

is the inclusion of safety assurance cases 

as part of the premarket submissions for 

new, changed, or modified infusion 

pumps submitted by device 

manufacturers. This guidance explains 

the Agency’s current thinking and 

provides recommendations on 

information to submit through the safety 

assurance case framework and 

postmarket surveillance of infusion 

pumps. 

In April 2010, the Agency issued the 

special control draft guidance entitled 

‘‘Draft Guidance for Industry and FDA 

Staff: Total Product Life Cycle: Infusion 

Pump—Premarket Notification [510(k)] 

Submissions’’ (Ref. 1). The Agency has 

reviewed the comments submitted for 

the 2010 guidance and has incorporated 

most of the recommendations in this 

final guidance. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the Agency’s 

current thinking on infusion pumps. 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 

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 ‘‘Total Product Life Cycle: Infusion 

Pumps; Guidance for Industry and FDA 

Staff’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 1780 

to identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3520), Federal Agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. This guidance also refers to 

previously approved information 

collections found in FDA regulations. 

The collections of information in 21 

CFR part 803 are approved under OMB 

control number 0910–0437; the 

collections of information in 21 CFR 

part 801 are approved under OMB 

control number 0910–0485; 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 820 are approved under OMB 

control number 0910–0073; the 

collections of information in 21 CFR 

part 822 are under OMB control number 

0910–0449; the collections of 

information in 21 CFR 56.115 are 

approved under OMB control number 

0910–0130; and the collections of 

information for safety assurance cases 

are approved under OMB control 

number 0910–0766. 

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. 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 71435 

VI. Reference 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

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

through Friday, and is available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site address in this reference 

section, but we are not responsible for 

any subsequent changes to the Web site 

after this document publishes in the 

Federal Register.) 

1. The FDA guidance entitled ‘‘Draft 

Guidance for Industry and FDA 

Staff: Total Product Life Cycle: 

Infusion Pump—Premarket 

Notification [510(k)] Submissions,’’ 

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

medicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/

ucm206153.htm. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28267 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0295] 

Guidance for Industry on Scale-Up 

Post-Approval Changes: 

Manufacturing Equipment Addendum; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a scale-up and postapproval changes (SUPAC) guidance for 

industry entitled ‘‘SUPAC: 

Manufacturing Equipment Addendum.’’ 

This replaces the draft guidance of the 

same name that combined and 

superseded ‘‘SUPAC IR/MR: Immediate 

Release and Modified Release Solid Oral 

Dosage Forms: Manufacturing 

Equipment Addendum,’’ published on 

January 1, 1999; and ‘‘SUPAC–SS: 

Nonsterile Semisolid Dosage Forms; 

Manufacturing Equipment Addendum,’’ 

published as a draft on December 1, 

1998. FDA revised the draft 

manufacturing equipment addenda to 

remove the equipment examples and to 

clarify the types of processes being 

referenced. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Food and Drug Administration, 10001 

New Hampshire Ave., Hillandale 

Building, 4th Floor, Silver Spring, MD 

20993. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Akm Khairuzzaman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3886. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a SUPAC guidance for industry entitled 

‘‘SUPAC: Manufacturing Equipment 

Addendum.’’ This guidance replaces the 

draft guidance of the same name that 

superseded the following guidances for 

industry: (1) ‘‘SUPAC IR/MR: Immediate 

Release and Modified Release Solid Oral 

Dosage Forms: Manufacturing 

Equipment Addendum,’’ published on 

January 1, 1999, and (2) ‘‘SUPAC–SS: 

Nonsterile Semisolid Dosage Forms; 

Manufacturing Equipment Addendum, 

‘‘published as draft on December 1, 

1998. When published, these guidances 

included tables that listed specific 

equipment that were misinterpreted as a 

list of FDA required equipment. In 

addition, FDA is concerned that the 

equipment addenda may no longer 

reflect current practices and may be 

limiting, instead of encouraging, 

manufacturers to continually evaluate 

and update practices. FDA has removed 

the tables listing specific manufacturing 

equipment from these guidances and 

combined them into a single addendum. 

FDA has also made some changes to 

clarify the types of processes being 

referenced. 

This guidance should be used with 

the following guidances for industry to 

determine what documentation should 

be submitted to FDA regarding 

equipment changes: (1) ‘‘SUPAC–IR: 

Immediate Release Solid Oral Dosage 

Forms—Scale-Up and Post-Approval 

Changes: Chemistry, Manufacturing and 

Controls, In Vitro Dissolution Testing, 

and In Vivo Bioequivalence 

Documentation,’’ (2) ‘‘SUPAC–MR: 

Modified Release Solid Oral Dosage 

Forms Scale-Up and Post-Approval 

Changes: Chemistry, Manufacturing and 

Controls; In Vitro Dissolution Testing 

and In Vivo Bioequivalence 

Documentation,’’ and (3) ‘‘SUPAC–SS: 

Nonsterile Semisolid Dosage Forms, 

Scale-Up and Post Approval Changes: 

Chemistry Manufacturing and Controls; 

In Vitro Release Testing and In Vivo 

Bioequivalence Documentation.’’ 

As part of a greater effort, FDA is 

thoroughly reviewing the SUPAC 

guidance series to determine how these 

guidances fit with current 

manufacturing practices, including, but 

not limited to, risk-based assessment 

approaches and quality by design 

principles. This guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). This guidance represents the 

Agency’s current thinking on 

manufacturing equipment. 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 statutes and regulations. 

II. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28256 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 


rljohnson on DSK3VPTVN1PROD with NOTICES