[Federal Register Volume 68, Number 23 (Tuesday, February 4, 2003)]
[Notices]
[Pages 5643-5644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2604]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
MDUFMA.
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://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
provisions:
[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
fee.
[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
populations.
[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://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
to MDUFMA.
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://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]
BILLING CODE 4160-01-S