[Federal Register Volume 78, Number 110 (Friday, June 7, 2013)]
[Notices]
[Pages 34392-34393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13484]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0179]


Guidance for Industry and Food and Drug Administration Staff: 
Technical Considerations for Pen, Jet, and Related Injectors Intended 
for Use With Drugs and Biological Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance document entitled ``Technical 
Considerations for Pen, Jet, and Related Injectors Intended for Use 
With Drugs and Biological Products,'' dated June 2013. The final 
guidance document provides technical and scientific

[[Page 34393]]

information for sponsors to consider in developing information to 
support a marketing application for a pen, jet, or related injector 
device intended for use with drugs or biological products. The 
marketing application would typically be a premarket notification 
submission (510(k)) or a premarket approval (PMA) application for the 
injector alone. For a combination product that includes the injector, 
the marketing application would typically be a new drug application 
(NDA) or a biological licensing application (BLA). The guidance 
announced in this notice finalizes the draft guidance of the same title 
dated April 2009 and published under Docket No. FDA-2009-D-0179.

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 Office of Combination Products, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. The guidance may also be obtained by mail by calling the 
Office of Combination Products at 301-796-8930. 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: Patricia Y. Love, Office of 
Combination Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry and FDA Staff: Technical Considerations for 
Pen, Jet, and Related Injectors Intended for Use With Drugs and 
Biological Products'' dated June 2013. FDA is providing this final 
guidance document to assist industry in developing technical and 
scientific information to support a marketing application for a pen, 
jet, or related injector device. The marketing application would 
typically be a 510(k) or a PMA application for the injector alone. For 
a combination product that includes the injector, the marketing 
application would typically be an NDA or a BLA. For purposes of this 
guidance, the term injector includes, but is not limited to, jet 
injectors, pen injectors, piston syringes, needle-free injectors, 
mechanically operated injectors, and injectors with computerized or 
electronic elements.
    In the Federal Register on April 27, 2009, (74 FR 19094), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and those comments were 
considered as the guidance was finalized. The final guidance is largely 
similar to the draft guidance. The significant changes to the guidance 
include: Additional information to clarify the bases for the technical 
and scientific recommendations for general use injectors, injectors 
intended for a class/family of drugs or biological products, injectors 
intended for a sponsor's product line, and injectors for use with a 
specific drug or biological product. The guidance provides additional 
information to assist developers in considering the relevance of 
already approved drug or biological product labeling in the development 
of injectors intended for general use or for use with a class/family or 
product line, which should assist in developing labeling for the 
injectors. The document provides links to other Agency documents 
published since the April 2009 draft guidance. Also, the document 
contains editorial and terminology changes to improve clarity and 
readability. The guidance announced in this notice finalizes the draft 
guidance dated April 2009.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review and have been approved 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 807 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 314 
have been approved under OMB control number 0910-0001. The collections 
of information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338.

III. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/CombinationProducts/default.htm or http://www.regulations.gov.

    Dated: May 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13484 Filed 6-6-13; 8:45 am]
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