[Federal Register: July 8, 2003 (Volume 68, Number 130)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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;
AGENCY: Food and Drug Administration, HHS.
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
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diskette of the draft guidance document entitled ``Guidance for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.
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
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.
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
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.
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.
Assistant Commissioner for Policy.
[FR Doc. 03-17135 Filed 7-7-03; 8:45 am]
BILLING CODE 4160-01-S