[Federal Register: April 13, 2004 (Volume 69, Number 71)]
[Page 19433-19435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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-


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 
    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:

    \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-

    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.

    \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.


    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
                                Product Code   Product Code   Code Name
   21 CFR     Classification        for             for          for
  Section          Name        Nonreprocessed   Reprocessed  Reprocessed
                                   Device         Device        Device
872.5410     Orthodontic      EJF              NQS           Orthodontic
              appliance and                                   metal
              accessories                                     bracket
876.4680     Ureteral stone   FGO, FFL         NQT, NQU      Flexible
              dislodger                                       and basket
868.6810     Tracheobronchia  BSY              NQV           Tracheobron
              l suction                                       chial
              catheter                                        suction

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 

[[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]