Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability, 71434-71435 [2014-28267]

Download as PDF 71434 Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices I. Background 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. 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 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: 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: rljohnson on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:30 Dec 01, 2014 Jkt 235001 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://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 https://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 https:// www.regulations.gov. E:\FR\FM\02DEN1.SGM 02DEN1 Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 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 https:// 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 https://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. 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. rljohnson on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:30 Dec 01, 2014 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 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. 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: DATES: Jkt 235001 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 71435 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 https://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 https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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 E:\FR\FM\02DEN1.SGM 02DEN1

Agencies

[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Pages 71434-71435]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28267]

[[Page 71434]]

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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 self-addressed adhesive label to assist
that office in processing your request.
Submit electronic comments on the 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: 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://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 https://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 https://www.regulations.gov.

[[Page 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 https://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 https://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

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