E9-9519. Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological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.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled “Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.” The draft guidance document provides technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or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).

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 27, 2009.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Combination Products, 15800 Crabbs Branch Way, Rockville, MD 20855. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling the Office of Combination Products at 301-427-1934 or by e-mail to [e-mail]. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Patricia Y. Love, Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 301-427-1934.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance document entitled “Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.” FDA is providing this draft 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.

II. Significance of Guidance

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on “Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.” 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.

III. Paperwork Reduction Act of 1995

This draft guidance contains information collection provisions that 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 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 21 CFR part 601 have been approved under OMB control number 0910-0338.

IV. Comments

The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/​oc/​combination/​ or http://www.regulations.gov.

Dated: April 20, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.