[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announced in this notice finalizes the draft guidance of the same title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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