[Federal Register: April 13, 2004 (Volume 69, Number 71)]
[Notices]
[Page 19433-19435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap04-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0154]
Medical Devices; Semicritical Reprocessed Single-Use Devices;
Termination of Exemptions From Premarket Notification; Requirement for
Submission of Validation Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a list
of semicritical reprocessed single-use devices (SUDs) whose exemption
from premarket submission is being terminated and for which validation
data, as specified under the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA), are necessary in a premarket notification
(510(k)). FDA is requiring submission of these data to ensure that
these reprocessed SUDs are substantially equivalent to predicate
devices in accordance with MDUFMA.
DATES: These actions are effective April 13, 2004. Manufacturers of
reprocessed SUDs identified in the list whose exemptions are being
terminated must submit 510(k)s for these devices by July 13, 2005, or
these devices may no longer be legally marketed.
ADDRESSES: Submit written comments 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: Barbara A. Zimmerman, Center for
Devices and Radiological Health (HFZ-410), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2036.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250) amended the
Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o)
(21 U.S.C. 360(o)), which provided new regulatory requirements for
reprocessed SUDs. According to this new provision, 510(k)s for certain
reprocessed SUDs identified by FDA must include validation data to
ensure that the reprocessed SUDs are substantially equivalent to
predicate devices. The required validation data include cleaning and
sterilization data, and functional performance data demonstrating that
each SUD will remain substantially equivalent to its predicate device
after the maximum number of times the device is reprocessed as intended
by the person submitting the premarket notification.
Before the enactment of the new law, the agency required a
manufacturer of a reprocessed SUD to obtain premarket approval or
premarket clearance for the device, unless the device was exempt from
premarket submission requirements. Under MDUFMA, some previously exempt
critical and semicritical reprocessed SUDs will no longer be exempt
from premarket notification requirements. Manufacturers of these
identified devices will need to submit 510(k)s that include validation
data as specified by FDA.
Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an
``original device that has previously been used on a patient and
has been subjected to additional processing and manufacturing for
the purpose of an additional single use on a patient. The subsequent
processing and manufacture of a reprocessed single-use device shall
result in a device that is reprocessed within the meaning of this
definition.''
Reprocessed SUDs are divided into the following three categories:
(1) Critical, (2) semicritical, and (3) noncritical. The first two
categories reflect definitions contained in MDUFMA, and all three
reflect a classification scheme recognized in the industry.\1\ These
categories of devices are defined as follows:
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\1\ Spaulding, E. H., ``The Role of Chemical Disinfection in the
Prevention of Nosocomial Infections,'' P. S. Brachman and T. C.
Eickof (ed), Proceedings of International Conference on Nosocomial
Infections, 1970, American Hospital Association, Chicago, 1971:254-
274.
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1. A critical reprocessed SUD is intended to contact normally
sterile tissue or body spaces during use.
2. A semicritical reprocessed SUD is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the body.
3. A noncritical reprocessed SUD is intended to make topical
contact and not penetrate intact skin.
In the Federal Register of April 30, 2003 (68 FR 23139), FDA
explained its methodology and criteria for determining which device
types should no longer be exempt from premarket submission requirements
in accordance with MDUFMA. As described in the April 2003 Federal
Register notice, in the first step of this process, the agency
categorized all known types of SUDs that were being reprocessed as
critical, semicritical, or noncritical using the previously listed
definitions. Next, FDA evaluated the overall risk (high, moderate, or
low) associated with the reprocessed SUDs using the review
prioritization scheme (RPS) that had been previously described in a
draft guidance document.\2\ In the RPS guidance, FDA set forth factors
that could be used to evaluate the risk associated with reprocessed
SUDs and assign an overall risk to each SUD based on the risk of the
following: (1) Infection and (2) inadequate performance following
reprocessing. The designation of ``high risk'' was assigned to those
devices that posed the greatest risk of infection and inadequate
performance after reprocessing.
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\2\ The draft guidance entitled ``Reprocessing and Reuse of
Single-Use Devices: Review Prioritization Scheme'' (appendix 2
superseded) is available on the Center for Devices and Radiological
Health's (CDRH) Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/reuse/1156.pdf.
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In addition to the previously listed steps, FDA also identified all
reprocessed SUDs intended to come in contact with tissue at high risk
of being infected with the causative agents of Creutzfeldt-Jakob
Disease (CJD). As stated in the April 2003 Federal Register notice,
these are generally devices intended for use in neurosurgery and
ophthalmology. This criterion was used in FDA's evaluation because
insufficient scientific information exists at this time to establish
standard methods to eliminate CJD infectious agents.
[[Page 19434]]
Using this process and criteria, FDA developed a reference list
(attachment 1 of the April 2003 Federal Register notice). This list
identifies the entire group of reprocessed SUDs, and the levels of risk
associated with the devices, that FDA considered when implementing the
new statutory requirements in section 510(o) of the act. (For more
detailed information on the process FDA used to identify these SUDs and
assign risk categorizations, see 68 FR 23139.)
II. Requirements for 510(k) Exempt Critical Reprocessed SUDs
In the April 2003 Federal Register notice, as required by MDUFMA,
FDA published a list of critical reprocessed SUDs whose exemptions from
premarket submission were being terminated and for which validation
data in 510(k) submissions would be necessary. In the notice, FDA
identified those critical reprocessed SUDs that were either ``high''
risk, as described previously, or intended to come in contact with
tissue at high risk of being infected with the causative agents of CJD
(see list I of the April 2003 Federal Register notice). FDA also
published a revised version of this list in the Federal Register of
June 26, 2003 (68 FR 38071).
III. Requirements for 510(k) Exempt Semicritical Reprocessed SUDs
As discussed previously, MDUFMA also requires FDA to review the
semicritical reprocessed SUDs that are currently exempt from premarket
notification requirements and determine which of these devices will
require 510(k)s with validation data in order to ensure their
substantial equivalence to predicate devices. FDA is required to
identify these devices in a notice published in the Federal Register by
April 26, 2004. The attached list of semicritical reprocessed SUDs
implements this MDUFMA requirement. Using the methodology and criteria
described in this document for developing the list of critical
reprocessed SUDs, the agency determined which semicritical reprocessed
SUDs should be subject to premarket submission requirements. All
devices identified in the attached list have been determined to be high
risk semicritical reprocessed SUDs. It should be noted that not all
exempt semicritical devices have been listed. Semicritical reprocessed
SUDs that are not listed at this time may be added to future updates of
the list.
As required by MDUFMA, manufacturers of the devices identified in
the attached list must submit 510(k)s that include validation data
regarding cleaning, sterilization, and functional performance, in
addition to all the other required elements of 510(k)s identified in 21
CFR 807.87, within 15 months of publication of this notice or they may
no longer legally market these devices after that date.
List 1.--Semicritical Reprocessed Single-Use Devices Previously Exempt
From Premarket Notification Requirements That Will Now Require 510(k)s
With Validation Data
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Product
Product Code Product Code Code Name
21 CFR Classification for for for
Section Name Nonreprocessed Reprocessed Reprocessed
Device Device Device
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872.5410 Orthodontic EJF NQS Orthodontic
appliance and metal
accessories bracket
876.4680 Ureteral stone FGO, FFL NQT, NQU Flexible
dislodger and basket
stone
dislodger
868.6810 Tracheobronchia BSY NQV Tracheobron
l suction chial
catheter suction
catheter
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IV. Requirements for 510(k) Exempt Noncritical Reprocessed SUDs
MDUFMA does not require FDA to take any action under section 510(o)
of the act for noncritical reprocessed SUDs that are exempt from
premarket submission requirements.
V. Stakeholder Input
In the Federal Register of February 4, 2003 (68 FR 5643), FDA
invited interested persons to provide information and share views on
the implementation of MDUFMA. Since that time, the agency has received
comments on various MDUFMA provisions, including several on its
implementation of section 510(o) of the act. One comment expressed
concern about the agency's reliance on the Review Prioritization Scheme
(RPS). According to the comment, the RPS is a subjective and incomplete
method for accurately assessing the risk associated with reprocessing.
The comment further stated that Congress's intent was for the Spaulding
criteria to be the primary mechanism used to determine whether the
exempt status of reprocessed SUDs remains appropriate.
As stated in the April 30, 2003 Federal Register notice, the agency
continues to believe that the RPS is an appropriate risk-based tool for
identifying those devices that are likely to raise concerns about both
infection transmission and inadequate performance following
reprocessing. FDA believes that the flowchart that is part of the RPS
provides an objective, science-based assessment of these risks for each
type of reprocessed device. In addition, while MDUFMA defines the terms
``critical reprocessed single-use device'' and ``semi-critical
reprocessed single-use device'' in new section 201(mm)(1) and (mm)(2)
of the act, new section 510(o)(2)(A) states that ``[t]he Secretary
shall identify such devices or types of devices for which such
exemptions should be terminated in order to provide a reasonable
assurance of the safety and effectiveness of the devices.'' Given this
statutory language, FDA believes that while Congress used the Spaulding
definitions to initially categorize reprocessed SUDs, Congress also
authorized the agency to apply additional criteria in determining the
devices for which 510(k) exemptions should be terminated.
The agency also received a comment that identified specific
reprocessed SUDs whose exemption from the 510(k) requirements should be
terminated. The agency considered these recommendations while
finalizing this document. Although this list of semicritical
reprocessed SUDs does not include all of those devices that were
recommended in the comment, the agency believes that 510(k)s with
validation data should be required in accordance with MDUFMA for the
devices identified on the list due to concerns about infection
transmission and performance. As stated in the April 2003 Federal
Register notice, the agency recognizes that the lists of critical and
semicritical devices may need to be reevaluated and updated over time.
Therefore, FDA will consider comments from the public on additional
devices
[[Page 19435]]
that should be included on the lists at any time.
Finally, FDA would like to take this opportunity to remind entities
that reprocess SUDs of the guidance document entitled ``Medical Device
User Fee and Modernization Act of 2002, Validation Data in Premarket
Notification Submissions [510(k)s] for Reprocessed Single-Use Medical
Devices.'' FDA announced the availability of this guidance in the
Federal Register of July 8, 2003 (68 FR 40679). This guidance document
provides FDA's recommendations for manufacturers of reprocessed SUDs to
assist them in complying with MDUFMA's validation data submission
requirement and should be helpful to manufacturers of those
semicritical reprocessed SUDs listed below in preparing their 510(k)s.
This guidance may be found on CDRH's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance/html
.
VI. Paperwork Reduction Act of 1995
This document contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information described in this document were approved
under OMB control number 0910-0514.
VII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document
at any time. Submit a single copy of electronic comments or 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. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8307 Filed 4-12-04; 8:45 am]
BILLING CODE 4160-01-S