[Federal Register: June 1, 2004 (Volume 69, Number 105)]
[Notices]
[Page 30943-30945]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn04-108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0309]
Guidance for Industry and Food and Drug Administation Staff;
Medical Device User Fee and Modernization Act of 2002, Validation Data
in Premarket Notification Submissions for Reprocessed Single-Use
Medical Devices; 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 revised guidance entitled ``Guidance for Industry
and FDA Staff; Medical Device User Fee and Modernization Act of 2002,
Validation Data in Premarket Notification Submissions (510(k)s) for
Reprocessed Single-Use Medical Devices'' (validation data guidance).
This guidance document is being revised to include the procedures and
timeframes that the agency intends to follow in its review of the
validation data required by the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA),
[[Page 30944]]
for certain reprocessed single-use devices (SUDs), to include updated
references to relevant Federal Register notices, and to include a
section addressing the Paperwork Reduction Act of 1995 (the PRA). This
guidance document is immediately in effect, but it remains subject to
comment in accordance with the agency's good guidance practices (GGPs).
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 ``Guidance for Industry and
FDA Staff; Medical Device User Fee and Modernization Act of 2002,
Validation Data in Premarket Notification Submissions (510(k)s) for
Reprocessed Single-Use Medical 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 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://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: Timothy A. Ulatowski, Center for
Devices and Radiological Health (HFZ-300), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4692.
SUPPLEMENTARY INFORMATION:
I. Background
Section 302(b) of MDUFMA (Public Law 2003D-0309) added new
requirements for reprocessed SUDs to section 510(o) of the act (21
U.S.C. 360(o)). One of these provisions required FDA to review the
reprocessed SUDs that were exempt from premarket notification
requirements and to determine which of these devices require the
submission of 510(k)s with validation data to ensure their substantial
equivalence to predicate devices. The new law also requires the
submission of validation data specified in the statute for certain
reprocessed SUDs, identified by FDA, that were already subject to
510(k) submission requirements when MDUFMA was enacted. The types of
validation data to be submitted include cleaning, sterilization, and
functional performance data.
On July 8, 2003, FDA issued guidance under the same title
describing the types of validation data that FDA recommended be
submitted to the agency to support a substantial equivalence
determination for the reprocessed SUDs for which validation data are
required by MDUFMA. FDA is now revising the guidance to include the
review procedures and timeframes the agency intends to follow when
processing the required validation data. This guidance supersedes the
July 8, 2003, document.
FDA is implementing this level 1 guidance upon issuance because it
is essential for the agency to provide immediate guidance on the
procedures and timeframes that FDA intends to follow in reviewing the
validation data required by MDUFMA. The agency has determined that, in
light of the need to provide immediate guidance to manufacturers of
reprocessed SUDs, a request for comments before issuance of this
revised guidance is not feasible. FDA is also considering additional
changes to the validation guidance based on comments and questions
received since this guidance was initially implemented. These changes
would be incorporated into a future revision of the guidance.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(21 CFR 10.115). The guidance represents the agency's current thinking
on validation data regarding the cleaning, sterilization, and
functional performance of reprocessed SUDs, as well as the procedures
and review times that should be used by FDA in evaluating these
validation data. 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 ``Guidance for Industry and FDA Staff; Medical Device
User Fee and Modernization Act of 2002, Validation Data in Premarket
Notification Submissions (510(k)s) for Reprocessed Single-Use Medical
Devices'' by fax machine, call the Center for Devices and Radiological
Health (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
(Office GGP Rep will insert DOC number) followed by the pound sign
(). Follow the remaining voice prompts to complete your
request.
Persons interested in obtaining a copy of the guidance 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 Division of Dockets
Management 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 contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the PRA (44 U.S.C. 3501-3520). 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 control number 0910-0120).
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) 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 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. Comments received may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 30945]]
Dated: May 25, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12362 Filed 5-26-04; 3:59 pm]
BILLING CODE 4160-01-S