[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]                         

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

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.

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

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