[Federal Register: November 26, 2003 (Volume 68, Number 228)]
[Notices]
[Page 66461-66463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no03-69]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0504]


Medical Devices; Guidance for Industry and FDA Staff; Bundling
Multiple Devices or Multiple Indications in a Single Submission;
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 the guidance entitled ``Bundling Multiple Devices or
Multiple Indications in a Single Submission.'' This guidance describes
FDA's policy on bundling multiple devices or multiple indications in a
single premarket submission. Under the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA), the bundling policy takes on
additional importance because of the fees that are now associated with
certain submissions as well as the performance goals the agency has
committed to meet. The guidance is being issued as final for immediate
implementation with an

[[Page 66462]]

opportunity for public comment on the guidance after issuance.

DATES: Submit written or electronic comments on this guidance at any
time.

ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Bundling Multiple Devices
or Multiple Indications in a Single Submission'' 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 two self-
addressed adhesive labels 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 guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
    For device evaluation issues: Bob Gatling, Office of Device
Evaluation, Center for Devices and Radiological Health (HFZ-404), Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-594-1190, ext. 140.
    For in vitro diagnostic device issues: Sousan Altaie, Office of In
Vitro Diagnostic Device Evaluation and Safety, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3084, ext. 145.
    For biologics issues: Sheryl Kochman, Center for Biologics
Evaluation and Research (HFM-390), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-6123

SUPPLEMENTARY INFORMATION:

I. Background

    MDUFMA amended the Federal Food, Drug, and Cosmetic Act by
authorizing FDA to collect user fees for certain premarket submissions
(premarket approval applications, premarket reports, supplements,
premarket notifications, biologics license applications, and efficacy
supplements) received on or after October 1, 2002. A letter from the
Secretary of Health and Human Services to Congress that accompanies the
user fee legislation sets forth performance goals and policy and
procedural provisions. One of these provisions is entitled ``Bundling
Policy'' and states that FDA will consider, in consultation with its
stakeholders, when bundling multiple devices in a single submission may
be appropriate. (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma/pgoals.html).
    This guidance describes FDA's policy on bundling multiple devices
or multiple indications in a single premarket submission and is
intended to help FDA staff and industry determine when bundling is
appropriate. In developing this guidance, the agency has considered
comments on the topic that were submitted to the public docket on
MDUFMA Implementation (Docket No. 02N-0534). FDA has also included in
the guidance many of the examples provided by stakeholders.

II. Significance of Guidance

    This guidance document supersedes Section V, ``Bundling Multiple
Devices in a Single Application'' of the February 2003 guidance
entitled, ``Assessing User Fees: PMA Supplement Definitions, Modular
PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple
Devices in a Single Application, and Fees for Combination Products;
Guidance for Industry and FDA.'' FDA announced the availability of that
guidance in the Federal Register of February 25, 2003 (68 FR 8773). As
discussed above, FDA reviewed the comments received on the issue of
bundling. FDA also invites comments on this guidance document (see
section V of this document).
    This guidance document is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the agency's current thinking on bundling multiple devices or multiple
indications in a single premarket submission. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations.
If you want to discuss an alternative approach, contact the FDA staff
responsible for implementing this guidance. If you cannot identify the
appropriate FDA staff, call one of the numbers listed above or on the
title page of the guidance document.

III. Electronic Access

    To receive ``Bundling Multiple Devices or Multiple Indications in a
Single Submission'' 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 (1215) followed by the
pound sign (). Follow the remaining voice prompts to complete
your request.
    Persons interested in obtaining a copy of the guidance document may
also do so by using the Internet. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.

guidance.html. Guidance documents are also available on the Dockets
Management Branch Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance document 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 USC 3501-3520) (the PRA).
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
governing premarket notification submissions (21 CFR part 807, subpart
E), OMB No. 0910-0120 and premarket approval applications (21 CFR part
814), OMB No. 0910-0231.

V. Comments

    Interested persons may submit to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, written or electronic comments regarding this
document. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Submit two hard copies of any mailed
comments, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments received may be seen in the Dockets

[[Page 66463]]

Management Branch between 9 a.m. and 4 p.m., Monday through Friday. FDA
will review any comments we receive and revise the guidance document
when appropriate.

    Dated: November 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29461 Filed 11-25-03; 8:45 am]

BILLING CODE 4160-01-S