05-20329. Draft Guidance for Industry and FDA Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended-Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended—Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices.” The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), as amended by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), requires that FDA issue guidance within 180 days of enactment (August 1, 2005) identifying the circumstances in which the name, abbreviation, or symbol identifying the manufacturer of an original device is not “prominent and conspicuous.”

DATES:

Submit written or electronic comments on this draft guidance so that they are received by close of business on November 10, 2005. FDA will not be able to consider comments received after that date in developing the final guidance. FDA may consider late comments at a future time if the guidance needs to be revised at a later date.

ADDRESSES:

Submit written requests for single copies on a 3.5″ diskette of the guidance document entitled “Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended—Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.fda.gov/​dockets/​ecomments. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Casper E. Uldriks, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0106.

SUPPLEMENTARY INFORMATION:

I. Background

MDUFMA (Public Law 107-250) amended section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352) to require a device, or an attachment to the device, to bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. This labeling provision applied to all devices and all device manufacturers, including reprocessors.

On August 1, 2005, MDUFSA (Public Law 109-43) amended section 502(u) of the act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Therefore, section 502(u) of the act, as amended by MDUFSA, no longer sets forth requirements for original equipment manufacturers, unless they also reprocess SUDs. Under the amended provision, if an original device or an attachment to it does not prominently and conspicuously bear the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, the manufacturer who reprocesses the SUD may identify itself using a detachable label on the packaging of the device.

Section 2(c)(2) of MDUFSA requires that FDA issue guidance not later than 180 days after the date of its enactment to identify the circumstances under which the identifying mark of a manufacturer of an original device is not “prominent and conspicuous,” as used in section 502(u) of the act. When finalized, this guidance document will satisfy this MDUFSA requirement. As stated previously, FDA requests that interested person submit their comments on the draft guidance within 30 days of its publication. FDA will consider these comments to determine whether to revise the guidance before issuing it in final form.

II. Significance of Guidance

This 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 “Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended—Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices.” 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

To receive “ Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended—Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices” by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1217) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the draft guidance may also do so by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/​cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/​ohrms/​dockets.

IV. Paperwork Reduction Act of 1995

This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In the Federal Register of September 29, 2005 (70 FR 56910), FDA published a 60-day notice soliciting comments on the information collection provisions contained in this guidance.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this draft guidance. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. 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 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.

Dated: October 3, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.