[Federal Register: July 8, 2003 (Volume 68, Number 130)]
[Notices]               
[Page 40679-40680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy03-79]                         


[[Page 40679]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0232]

 
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; 
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 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). 
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), 
added a section to the act to establish new regulatory requirements for 
reprocessed single-use devices (SUDs). MDUFMA was signed into law on 
October 26, 2002. One requirement of the new provision is the 
submission of validation data for certain class I and II reprocessed 
SUDs. This guidance document is intended to assist manufacturers of 
reprocessed SUDs in understanding and complying with this new MDUFMA 
requirement. The new section of MDUFMA establishes requirements 
applicable only to reprocessed SUDs.

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diskette of the draft guidance document entitled ``Guidance for 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 (CDRH), 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.
    Submit written comments concerning the 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://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Timothy A. Ulatowski, Center for 
Devices and Radiological Health (HFZ-300), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4692.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 302(b) of MDUFMA adds new requirements for reprocessed SUDs 
to section 510 of the act (21 U.S.C. 360). One of MDUFMA's provisions 
requires the submission of validation data specified in the statute for 
certain reprocessed SUDs (as identified by FDA). The types of 
validation data include cleaning and sterilization data, and functional 
performance data.
    MDUFMA requires that FDA review the types of reprocessed SUDs now 
subject to premarket notification requirements and identify which of 
these devices require the submission of validation data to ensure their 
substantial equivalence to predicate devices. MDUFMA also requires that 
FDA review critical and semicritical reprocessed SUDs that are 
currently exempt from premarket notification requirements and determine 
which of these devices requires the submission of 510(k)s to ensure 
their substantial equivalence to predicate devices. Under MDUFMA, the 
validation data submitted for a reprocessed SUD must demonstrate that 
the device will remain substantially equivalent to its predicate after 
the maximum number of times the device is reprocessed as intended by 
the person submitting the premarket notification.
    MDUFMA required that FDA publish two lists in the Federal Register 
by April 26, 2003, concerning the following: (1) A list of critical 
reprocessed SUDs whose exemption from 510(k) requirements will be 
terminated, and (2) a list of reprocessed SUDs that are currently 
subject to 510(k) requirements for which validation data must be 
submitted. FDA will update these lists as necessary. MDUFMA specifies 
timeframes during which the validation data must be submitted for 
reprocessed SUDs on these lists. This guidance document describes the 
types of validation data that FDA recommends these submissions include. 
Additionally, the guidance explains the effect of the validation data 
requirement on reprocessed SUDs that had been cleared, or had 
applications pending, before the publication of the lists.
    FDA is implementing this level 1 guidance document upon issuance 
because it is essential for the agency to provide immediate guidance on 
the validation data required by MDUFMA. Under MDUFMA, manufacturers of 
reprocessed SUDs have a limited time period during which they can 
develop and submit this validation data. The agency has determined, in 
light of the need to provide immediate guidance to these manufacturers, 
that a request for comments before issuance of this guidance is not 
feasible. The data submission recommendations set forth in this 
guidance will become effective immediately after approval by the Office 
of Management and Budget (OMB) of the collection of information 
proposed by FDA in this guidance. In developing this guidance, the 
agency has considered comments on the topic that were submitted to the 
public docket on MDUFMA implementation, docket number 02N-0534.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices 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. 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 the contact person 
(see FOR FURTHER INFORMATION CONTACT).
    The guidance provides information on the validation data for 
reprocessed SUDs required by MDUFMA. In some cases, FDA may have 
already published product-specific guidance, other relevant guidance 
that applies to the same type of device, or guidance that is generally 
applicable to premarket submissions. MDUFMA and this validation data 
guidance supersede any existing guidance that recommends less complete 
data and information than described in this validation data guidance.

[[Page 40680]]

III. Electronic Access

    To receive ``Guidance for Industry and FDA; 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 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 (1216) 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://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 Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This notice and the guidance entitled ``Guidance for Industry and 
FDA; Medical Device User Fee and Modernization Act of 2002, Validation 
Data in Premarket Notification Submissions [510(k)s] for Reprocessed 
Single-Use Medical Devices'' contain a proposed collection of 
information that requires clearance by OMB under the Paperwork 
Reduction Act of 1995. In a document published elsewhere in this issue 
of the Federal Register, FDA is announcing that this proposed 
collection of information has been submitted to OMB for emergency 
processing. The notice also solicits comments concerning the proposed 
collection of information.
    FDA will publish a separate notice in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions contained in this notice and the 
guidance. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

V. Comments

    You may submit written or electronic comments regarding this 
guidance to the Division of Dockets Management (see ADDRESSES). You 
should submit two copies of a written comment or one copy of an 
electronic comment. Individuals may submit one copy of a written 
comment. You should identify comments with the docket number found in 
brackets in the heading of this document. The guidance document and 
comments are available in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: June 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17135 Filed 7-7-03; 8:45 am]

BILLING CODE 4160-01-S