[Federal Register Volume 68, Number 228 (Wednesday, November 26, 2003)]
[Notices]
[Pages 66461-66463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29461]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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://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://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://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 Dockets 
Management Branch Internet site at 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://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