[Federal Register: February 4, 2003 (Volume 68, Number 23)]
[Page 5643-5644]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 02N-0534]

Medical Device User Fee and Modernization Act of 2002; 
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to obtain input on implementation of the Medical Device 
User Fee and Modernization Act of 2002 (MDUFMA). FDA is establishing 
this docket in order to provide an opportunity for all interested 
persons to provide information and share views on the implementation of 

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the docket 
number found in brackets in the heading of this document. 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.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION: MDUFMA (Public Law 107-250) amends the 
Federal Food, Drug, and Cosmetic Act to provide FDA important new 
responsibilities, resources, and challenges. MDUFMA was signed into

[[Page 5644]]

law October 26, 2002. MDUFMA has three particularly significant 
    [sbull] User fees for premarket reviews. Premarket approval 
applications (PMAs), product development protocols (PDPs), biologics 
license application (BLAs), premarket reports, certain supplements, and 
510(k)s are now subject to fees. The revenues from these fees, and from 
additional appropriations for infrastructure, will allow FDA to pursue 
a set of ambitious performance goals that will provide patients earlier 
access to safe and effective technology, and will provide more 
interactive and rapid review to the medical device industry. A small 
business (sales and receipts of $30 million or less) may pay a reduced 
    [sbull] Establishment inspections may be conducted by accredited 
persons (third-parties) under carefully prescribed conditions.
    [sbull] New regulatory requirements for reprocessed single-use 
devices, including provisions establishing a new category of premarket 
submission, the premarket report, and provisions requiring the 
submission of additional data on devices now being reprocessed.
    MDUFMA makes several other significant changes that are less 
complex or have a narrower scope than the major changes discussed 
previously. These include the following:
    [sbull] The review of combination products (products that combine 
elements of devices, drugs, or biologics) will be coordinated by a new 
office in the Office of the Commissioner of Food and Drugs.
    [sbull] Electronic labeling is authorized for prescription devices 
intended to be used in health care facilities.
    [sbull] FDA may require electronic registration of device 
establishments, when feasible.
    [sbull] The law now explicitly provides for modular review of PMAs.
    [sbull] New provisions concerning devices intended for pediatric 
use, including provisions for pediatric experts on advisory panels and 
the development of guidance for clinical trials involving pediatric 
    [sbull] The manufacturer of a device must be identified on the 
device itself, with certain exceptions.
    A letter from the Secretary of Health and Human Services that 
accompanies the user fee legislation sets forth the performance goals 
the agency has pledged to meet over the next 5 years. These goals 
represent the improvements FDA's device review program can achieve, 
monitor, and meet with industry cooperation. To help meet these 
performance goals, FDA will need to develop clear definitions of terms 
such as ``panel-track supplement,'' ``180-day supplement,'' and ``real-
time supplement.'' The agency will also need to develop a policy to 
define when bundling multiple devices, device modifications, or 
indications for use into a single submission is appropriate versus when 
separate applications should be submitted.
    FDA invites interested persons to submit comments on any or all of 
the previous issues, as well as other provisions of the new law. (A 
copy of the statute is available on the agency's MDUFMA Web site at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma/index.html). FDA hopes this docket will 
become an important tool for receiving information from interested 
parties and for public availability of that information. In the future, 
FDA expects to use its MDUFMA Web site to request input to the docket 
from stakeholders on a variety of specific questions and issues related 
    At this time, the agency is particularly interested in receiving 
comments from stakeholders about several provisions that must be 
immediately implemented to track and monitor the performance goals FDA 
has pledged to meet over the next few years. Specifically, the agency 
is seeking input on the following: (1) Defining the various types of 
PMA supplements; (2) implementing the modular review program for PMAs; 
(3) establishing a bundling policy to determine when it is appropriate 
to bundle multiple devices, device modifications, or indications for 
use into a single submission; and (4) gathering information for the 
pediatric device guidance document.
    On a related matter, MDUFMA also provides for the education and 
training of stakeholders to assist the agency in developing training 
programs. FDA invites comments on: (1) Possible subject matter or areas 
to be included in training programs for FDA employees or industry and 
(2) subject matter or courses that industry would be willing to provide 
to FDA employees. Past examples would include sterilization.
    FDA will consider all information and views that it receives during 
the implementation process. FDA will continue to work with interested 
parties through a variety of means to obtain as much information as 
possible to assist in the implementation process.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments. 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 or two 
copies of any written comments, except that individuals may submit one 
hard 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: January 29, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2604 Filed 2-3-03; 8:45 am]