Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Companion to Direct Final Rule, 55748-55755 [06-8165]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 185 (Monday, September 25, 2006)]
[Proposed Rules]
[Pages 55748-55755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8165]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / 
Proposed Rules

[[Page 55748]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 
and 892

[Docket No. 2006N-0335]


Medical Devices; Reprocessed Single-Use Devices; Requirement for 
Submission of Validation Data; Companion to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend certain classification regulations to reflect the termination of 
certain device exemptions and the requirement to submit validation data 
for specific reprocessed single-use devices (SUDs), as required by the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA). This 
proposed rule is a companion document to a direct final rule published 
elsewhere in this issue of the Federal Register. This proposed rule 
will provide a procedural framework to finalize the rule in the event 
we receive any significant adverse comment and withdraw the direct 
final rule. This proposed rule would codify actions taken in previous 
Federal Register notices in accordance with MDUFMA.

DATES: Submit written or electronic comments by December 11, 2006.

ADDRESSES: You may submit comments, identified by Docket No. 2006N-
0335, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to https://www.fda.gov/ohrms/dockets/
default.htm, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190, ext. 143.

SUPPLEMENTARY INFORMATION:

I. Why Is This Rule Being Issued as a Companion Proposed Rule?

    This proposed rule is a companion to the direct final rule that is 
published in the final rules section of this issue of the Federal 
Register. The direct final rule would amend certain classification 
regulations for reprocessed single-use devices (SUDs) whose exemption 
from premarket notification (510(k)) requirements have been terminated 
and other reprocessed SUDs already subject to premarket notification 
for which validation data, as specified under MDUFMA, are necessary in 
a 510(k). The direct final rule and this companion proposed rule are 
identical. We are publishing the direct final rule because we believe 
the rule contains noncontroversial changes and minor corrections to 
existing regulations, and we anticipate that it will receive no 
significant adverse comment. A detailed discussion of the rule is set 
forth in the preamble of the direct final rule. If no significant 
adverse comment is received in response to the direct final rule, no 
further action will be taken related to this proposed rule. Instead, we 
will publish a confirmation document within 30 days after the comment 
period ends confirming when the direct final rule will go into effect. 
You can find additional information about FDA's direct final rulemaking 
procedures in the guidance document entitled ``Guidance for FDA and 
Industry: Direct Final Rule Procedures'' (62 FR 62466, November 21, 
1977). This guidance document may be accessed at https://www.fda.gov/
opacom/morechoices/industry/guidance.htm.
    If we receive any significant adverse comment regarding the direct 
final rule, we will withdraw the direct final rule within 30 days after 
the comment period ends and proceed to respond to all of the comments 
under this companion proposed rule using usual notice-and-comment 
rulemaking procedures under the Administrative Procedure Act (APA) (5 
U.S.C. 552a et seq). The comment period for this companion proposed 
rule runs concurrently with the direct final rule's comment period. Any 
comments received under this companion proposed rule will also be 
considered as comments regarding the direct final rule. A significant 
adverse comment is defined as a comment that explains why the rule 
would be inappropriate, including challenges to the rule's underlying 
premise or approach, or would be ineffective or unacceptable without a 
change. In determining whether an adverse comment is significant and 
warrants terminating a direct final rulemaking, we will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-

[[Page 55749]]

comment process in accordance with section 553 of the APA (5 U.S.C. 
553). Comments that are frivolous, insubstantial, or outside the scope 
of the rule will not be considered adverse under this procedure. For 
example, a comment recommending an additional change to the rule will 
not be considered a significant adverse comment, unless the comment 
states why the rule would be ineffective without the additional change. 
In addition, if a significant adverse comment applies to part of a rule 
and that part can be severed from the remainder of the rule, we may 
adopt as final those parts of the rule that are not the subject of a 
significant adverse comment.

II. What Is the Background of the Rule?

    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. The new provision requires validation data to be 
included in the premarket notification (510(k)) for certain reprocessed 
SUDs, to ensure that reprocessed SUDs are substantially equivalent to 
predicate devices. The validation data includes 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.
    Before enactment of the new law, a manufacturer of a reprocessed 
SUD was required to obtain premarket approval or premarket clearance 
for the device, unless the device was exempt from premarket submission 
requirements. Under MDUFMA, some previously exempt reprocessed SUDs are 
no longer exempt from premarket notification requirements. 
Manufacturers of these identified devices were required to submit 
510(k)s that included validation data specified by FDA. Reprocessors of 
certain SUDs already subject to cleared 510(k)s were also required to 
submit the validation data specified by the agency.

A. Definitions

    Under section 201(ll)(2)(A) of the act (21 U.S.C. 321(ll)(2)(A)), 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.'' FDA is amending Sec.  807.3 (21 CFR 
807.3) by adding paragraph (t) to incorporate this definition into the 
regulations.
    Reprocessed SUDs are divided into three groups: (1) Critical, (2) 
semicritical, and (3) noncritical. The first two categories are set 
forth in the act and all three reflect a categorization scheme 
recognized in the industry (Ref. 1). In the Federal Register of April 
30, 2003 (68 FR 23139), FDA describes in more detail the development of 
this scheme and its use in the implementation of section 510(o) of the 
act. The act defines critical and semicritical reprocessed single use 
devices at section 201(mm) as amended by MDUFMA. FDA defined 
noncritical devices in the Federal Register of April 30, 2003. The 
definitions are as follows:
     A critical reprocessed SUD is intended to contact normally 
sterile tissue or body spaces during use.
     A semicritical reprocessed SUD is intended to contact 
intact mucous membranes and not penetrate normally sterile areas of the 
body.
     A noncritical reprocessed SUD is intended to make topical 
contact and not penetrate intact skin.

B. Critical and Semicritical Reprocessed SUDs Previously Exempt from 
Premarket Notification

    MDUFMA required FDA to review the critical and semicritical 
reprocessed SUDs that were previously exempt from premarket 
notification requirements and determine which of these devices required 
premarket notification to ensure their substantial equivalence to 
predicate devices. Under MDUFMA, FDA was required to identify in a 
Federal Register notice those critical reprocessed SUDs whose exemption 
from premarket notification would be terminated and for which FDA 
determined that validation data, as specified under MDUFMA, was 
necessary in a 510(k). FDA published a list of these devices on April 
30, 2003. According to the law, manufacturers of the devices whose 
exemptions from premarket notification were terminated were required to 
submit 510(k)s that included validation data regarding cleaning, 
sterilization, and functional performance, in addition to all the other 
required elements of a 510(k) identified in Sec.  807.87 (21 CFR 
807.87), within 15 months of publication of the notice or no longer 
market their devices.
    In accordance with section 510(o) of the act, FDA must revise the 
list of devices subject to this requirement as appropriate. In the 
Federal Register of June 26, 2003 (68 FR 38071), FDA recategorized nine 
device types from semicritical to critical, and added nonelectric 
gastroenterology-urology biopsy forceps to the list of critical 
reprocessed SUDs whose exemption from premarket notification 
requirements was being terminated. In the Federal Register of September 
29, 2005 (70 FR 56911), FDA announced that it was adding devices to the 
list of critical reprocessed SUDs whose 510(k) exemption is terminated 
and for which validation data is necessary.
    By April 26, 2004, FDA was required to identify in a Federal 
Register notice those semicritical reprocessed SUDs whose exemption 
from premarket notification would be terminated and for which FDA 
determined that validation data, as specified under MDUFMA, was 
necessary in a 510(k). FDA published this list in the Federal Register 
of April 13, 2004 (69 FR 19433). As discussed previously in this 
document, manufacturers of the devices whose exemptions from premarket 
notification were terminated were required to submit 510(k)s that 
included validation data regarding cleaning, sterilization, and 
functional performance, in addition to all the other required elements 
of a 510(k) identified in Sec.  807.87, within 15 months of publication 
of the notice or no longer market their devices. In accordance with 
section 510(o) of the act, FDA must revise the list of devices subject 
to this requirement as appropriate.

C. Reprocessed SUDs Already Subject to Premarket Notification 
Requirements

    MDUFMA also required FDA to review the types of reprocessed SUDs 
already subject to premarket notification requirements and to identify 
which of these devices required the submission of validation data to 
ensure their substantial equivalence to predicate devices. FDA 
published a list of these devices in the Federal Register of April 30, 
2003. As described previously in this document, FDA must revise the 
list of devices subject to this requirement as appropriate. In the 
Federal Register of September 29, 2005, FDA announced that it was 
adding laparoscopic and endoscopic electrosurgical accessories to this 
list of reprocessed SUDs already subject to premarket notification.
    For devices identified on this list that had already been cleared 
through the 510(k) process, manufacturers were required to submit 
validation data regarding cleaning, sterilization, and functional 
performance within 9 months of publication of the list or no longer 
market their devices.
    For devices on this list that were not yet cleared through the 
510(k) process, manufacturers were required to submit

[[Page 55750]]

510(k)s with validation data regarding cleaning, sterilization, and 
functional performance, in addition to all the other required elements 
identified in Sec.  807.87.

III. What Does This Proposed Rule Do?

    As described previously in this document, we have already taken 
actions required under section 510(o) of the act. This proposed rule 
would codify these actions, including revocations of exemption from 
premarket notification for SUDs and the requirement to submit 
validation data, and add definitions based on the statute to 21 CFR 
part 807. The proposed rule does not make any substantive changes to 
existing requirements. We have included a detailed description of 
specific changes in the rule in the preamble to the direct final rule, 
published elsewhere in this issue of the Federal Register.
    FDA has made available previously a guidance document on the 
submission of validation data 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'' (69 
FR 30943, June 1, 2004). This guidance document may be accessed on the 
Internet at https://www.fda.gov/cdrh/ode/guidance/1216.html.

IV. What Is the Legal Authority for This Proposed Rule?

    This proposed rule is authorized by sections 201, 301, 501, 502, 
510, 513, 515, 519, 520, 701, 704, 801, and 903 of the act and sections 
264 and 271 of the Public Health Service Act (21 U.S.C. 321, 331, 351, 
352, 360, 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C. 264 and 
271) .

V. What Is the Environmental Impact of This Proposed Rule?

    We have determined under 21 CFR 25.30(h) and 25.34(a) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VI. What Is the Economic Impact of This Proposed Rule?

    We have examined the impacts of the rule under Executive Order 
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). We believe that this 
proposed rule is not a significant regulatory action as defined by the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this proposed rule will not change any 
existing requirements or impose any new requirements, we certify that 
the proposed rule, if finalized, will not have a significant economic 
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $118 million, using the most current (2004) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information addressed in the proposed rule 
have been approved by OMB in accordance with the PRA under the 
regulations governing premarket notifications (21 CFR part 807, OMB 
control number 0910-0120).

VIII. What Are the Federalism Impacts of This Proposed Rule?

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the rule does not contain policies that have substantial direct effects 
on the States, on the relationship between the National Government and 
the States, or on the distribution of power and responsibilities among 
the various levels of government. Accordingly, we have concluded that 
the rule does not contain policies that have federalism implications as 
defined in the Executive order and, consequently, a federalism summary 
impact statement is not required.

IX. How Do You Submit Comments on This Proposed Rule?

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this proposed 
rule. 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.

X. What Is the Reference for This Rule?

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 am. and 4 pm., Monday through Friday.
    1. Spaulding, E. H., ``The Role of Chemical Disinfection in the 
Prevention of Nonsocomial Infections.'' Edited by P. S. Brachman and 
T. C. Eickof, Proceedings of International Conference on Nonsocomial 
Infections, 1970, American Hospital Association, Chicago, 254-274, 
1971.

List of Subjects

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Parts 868, 870, 872, 874, 876, 878, 880, 882, and 884

    Medical devices.

21 CFR Part 886

    Medical devices, Opthalmic goods and services.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 807, 868, 870, 872, 874, 876, 878, 880, 882, 
884, 886, and 892 be amended as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

    1. The authority citation for 21 CFR part 807 continues to read as 
follows:


[[Page 55751]]


    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271

    2. Section 807.3 is amended by adding new paragraphs (t), (u), and 
(v) to read as follows:


Sec.  807.3  Definitions.

* * * * *
    (t) A single use device (SUD) means a device that is intended for 
one use or on a single patient during a single procedure.
    (u) A reprocessed SUD is 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 SUD 
shall result in a device that is reprocessed within the meaning of this 
definition.
    (v) Validation data for the purposes of this part means cleaning 
and sterilization data, and functional performance data demonstrating 
that an 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.
    3. Section 807.87 is amended by redesignating paragraphs (h), (i), 
(j), (k), and (l) as paragraphs (i), (j), (k), (l), and (m), 
respectively, and by adding new paragraph (h) to read as follows:


Sec.  807.87  Information required in a premarket notification 
submission.

* * * * *
    (h) If the device is a reprocessed SUD that FDA has identified as 
requiring validation data, the premarket notification submission must 
include validation data as defined in Sec.  807.3(v).
* * * * *

PART 868--ANESTHESIOLOGY DEVICES

    4. The authority citation for 21 CFR part 868 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    5. Section 868.5150 is amended by revising paragraph (b) to read as 
follows:


Sec.  868.5150  Anesthesia conduction needle.

* * * * *
    (b) Classification. Class II (special controls). If the device is 
an anesthetic conduction needle (with/without introducer) or a short 
term spinal needle and it is a reprocessed single use device (SUD) as 
defined in Sec.  807.3(u) of this chapter, a premarket notification 
submission for the device must include validation data as described in 
Sec.  807.3(v).
    6. Section 868.5730 is amended by revising paragraph (b) to read as 
follows:


Sec.  868.5730  Tracheal tube.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    7. Section 868.5905 is amended by revising paragraph (b) to read as 
follows:


Sec.  868.5905  Noncontinuous ventilator (IPPB).

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
noncontinuous ventilator (respirator) mask that is a reprocessed single 
use device (SUD) as defined in Sec.  807.3(u) of this chapter, a 
premarket notification submission for the device must include 
validation data as described in Sec.  807.3(v).
    8. Section 868.6810 is amended by revising paragraph (b) to read as 
follows:


Sec.  868.6810  Tracheobronchial suction catheter.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  868.9. If the 
device is a reprocessed single use device (SUD) as defined in Sec.  
807.3(u) of this chapter, the exemption from premarket notification 
does not apply and the manufacturer must submit a premarket 
notification that includes validation data as described in Sec.  
807.3(v).

PART 870--CARDIOVASCULAR DEVICES

    9. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    10. Section 870.1200 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1200  Diagnostic intravascular catheter.

* * * * *
    (b) Classification. Class II (special controls). If the device is 
an angiography catheter that is a reprocessed single use device (SUD) 
as defined in Sec.  807.3(u) of this chapter, a premarket notification 
submission for the device must include validation data as described in 
Sec.  807.3(v).
    11. Section 870.1220 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1220  Electrode recording catheter or electrode recording 
probe.

* * * * *
    (b) Classification. Class II (special controls). If the device is 
an electrode recording catheter or intracardiac mapping catheter that 
is a reprocessed single use device (SUD) as defined in Sec.  807.3(u) 
of this chapter, a premarket notification submission for the device 
must include validation data as described in Sec.  807.3(v).
    12. Section 870.1230 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1230  Fiberoptic oximeter catheter.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    13. Section 870.1280 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1280  Steerable catheter.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    14. Section 870.1290 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1290  Steerable catheter control system.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    15. Section 870.1330 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1330  Catheter guide wire.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    16. Section 870.1390 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1390  Trocar.

* * * * *
    (b) Classification. Class II (special controls). If the device is a

[[Page 55752]]

 cardiovascular trocar that is a reprocessed single use device (SUD) as 
defined in Sec.  807.3(u) of this chapter, a premarket notification 
submission for the device must include validation data as described in 
Sec.  807.3(v).
    17. Section 870.1650 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1650  Angiographic injector and syringe.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    18. Section 870.1670 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.1670  Syringe actuator for an injector.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    19. Section 870.2700 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.2700  Oximeter.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
tissue saturation oximeter or an oximeter and it is a reprocessed 
single use device (SUD) as defined in Sec.  807.3(u) of this chapter, a 
premarket notification submission for the device must include 
validation data as described in Sec.  807.3(v).
    20. Section 870.3535 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.3535  Intra-aortic balloon and control system.

* * * * *
    (b) Classification. Class III (premarket approval). If the device 
is a reprocessed single use device (SUD) as defined in Sec.  807.3(u) 
of this chapter, a premarket notification submission for the device 
must include validation data as described in Sec.  807.3(v).
* * * * *
    21. Section 870.4450 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.4450  Vascular clamp.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    22. Section 870.4500 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.4500  Cardiovascular surgical instruments.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9. If the 
device is a noncompression heart stabilizer that is a reprocessed 
single use device (SUD) as defined in Sec.  807.3(u) of this chapter, 
the exemption from premarket notification does not apply and the 
manufacturer must submit a premarket notification that includes 
validation data as described in Sec.  807.3(v).
    23. Section 870.4885 is amended by revising paragraph (b) to read 
as follows:


Sec.  870.4885  External vein stripper.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).

PART 872--DENTAL DEVICES

    24. The authority citation for 21 CFR part 872 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    25. Section 872.3240 is amended by revising paragraph (b) to read 
as follows:


Sec.  872.3240  Dental bur.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9. If the 
device is a dental diamond coated bur that is a reprocessed single use 
device (SUD) as defined in Sec.  807.3(u) of this chapter, the 
exemption from premarket notification does not apply and the 
manufacturer must submit a premarket notification submission that 
includes validation data as described in Sec.  807.3(v).
    26. Section 872.4535 is amended by revising paragraph (b) to read 
as follows:


Sec.  872.4535  Dental diamond instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9. If the 
device is a reprocessed single use device (SUD) as defined in Sec.  
807.3(u) of this chapter, the exemption from premarket notification 
does not apply and the manufacturer must submit a premarket 
notification that includes validation data as described in Sec.  
807.3(v).
    27. Section 872.4730 is amended by revising paragraph (b) to read 
as follows:


Sec.  872.4730  Dental injecting needle.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9. If the 
device is a reprocessed single use device (SUD) as defined in Sec.  
807.3(u) of this chapter, the exemption from premarket notification 
does not apply and the manufacturer must submit a premarket 
notification that includes validation data as described in Sec.  
807.3(v).
    28. Section 872.5410 is amended by revising paragraph (b) to read 
as follows:


Sec.  872.5410  Orthodontic appliance and accessories.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9. If the 
device is a orthodontic metal bracket that is a reprocessed single use 
device (SUD) as defined in Sec.  807.3(u) of this chapter, the 
exemption from premarket notification does not apply and the 
manufacturer must submit a premarket notification that includes 
validation data as described in Sec.  807.3(v).
    29. Section 872.5470 is amended by revising paragraph (b) to read 
as follows:


Sec.  872.5470  Orthodontic plastic bracket.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, the exemption from premarket notification does not apply 
and the manufacturer must submit a premarket notification that includes 
validation data as described in Sec.  807.3(v).

PART 874--EAR, NOSE, AND THROAT DEVICES

    30. The authority citation for 21 CFR part 874 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    31. Section 874.4140 is amended by revising paragraph (b) to read 
as follows:

[[Page 55753]]

Sec.  874.4140  Ear, nose, and throat bur.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9. If the 
device is an ear, nose, and throat (ENT) high speed microdebrider or an 
ENT diamond coated bur and it is a reprocessed single use device (SUD) 
as defined in Sec.  807.3(u) of this chapter, the exemption from 
premarket notification does not apply and the manufacturer must submit 
a premarket notification that includes validation data as described in 
Sec.  807.3(v).
    32. Section 874.4420 is amended by revising paragraph (b) to read 
as follows:


Sec.  874.4420  Ear, nose, and throat manual surgical instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9. If the 
device is a laryngeal, sinus, or tracheal trocar that is a reprocessed 
single use device (SUD) as defined in Sec.  807.3(u) of this chapter, 
the exemption from premarket notification does not apply and the 
manufacturer must submit a premarket notification that includes 
validation data as described in Sec.  807.3(v).
    33. Section 874.4680 is amended by revising paragraph (b) to read 
as follows:


Sec.  874.4680  Bronchoscope (flexible or rigid) and accessories.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
bronchoscope (nonrigid) biopsy forceps that is a reprocessed single use 
device (SUD) as defined in Sec.  807.3(u) of this chapter, a premarket 
notification submission for the device must include validation data as 
described in Sec.  807.3(v).

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    34. The authority citation for 21 CFR part 876 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    35. Section 876.1075 is amended by revising paragraph (b) to read 
as follows:


Sec.  876.1075  Gastroenterology-urology biopsy instrument.

* * * * *
    (b) Classification. (1) Class II (special controls). If the device 
is a gastroenterology-urology (G-U) biopsy needle and needle set or a 
biopsy instrument and it is a reprocessed single use device (SUD) as 
defined in Sec.  807.3(u) of this chapter, a premarket notification 
submission for the device must include validation data as described in 
Sec.  807.3(v).
    (2) Class I (general controls) for the biopsy forceps cover and the 
non-electric biopsy forceps. The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec.  
876.9. If the device is a non-electric biopsy forceps that is a 
reprocessed SUD as defined in Sec.  807.3(u) of this chapter, the 
exemption from premarket notification does not apply and the 
manufacturer must submit a premarket notification that includes 
validation data as described in Sec.  807.3(v).
    36. Section 876.1500 is amended by revising paragraph (b)(1) to 
read as follows:


Sec.  876.1500  Endoscope and accessories.

* * * * *
    (b) Classification. (1) Class II (special controls). If the device 
is an endoscopic needle, an endoilluminator, a general and plastic 
surgery laparoscope, or a spring-loaded pneumoperitoneum needle and it 
is a reprocessed single use device (SUD) as defined in Sec.  807.3(u) 
of this chapter, a premarket notification submission for the device 
must include validation data as described in Sec.  807.3(v).
* * * * *
    37. Section 876.4300 is amended by revising paragraph (b) to read 
as follows:


Sec.  876.4300  Endoscopic electrosurgical unit and accessories.

* * * * *
    (b) Classification. Class II (special controls). If the device is 
an active urological electrosurgical electrode, a flexible suction 
coagulator electrode, an electric biopsy forceps, a flexible snare, or 
an endoscopic (with or without accessories) electrosurgical unit that 
is a reprocessed single use device (SUD) as defined in Sec.  807.3(u) 
of this chapter, a premarket notification submission for the device 
must include validation data as described in Sec.  807.3(v).
    38. Section 876.4680 is amended by revising paragraph (b) to read 
as follows:


Sec.  876.4680  Ureteral stone dislodger.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9. If the 
device is a flexible and basket stone dislodger that is a reprocessed 
single use device (SUD) as defined in Sec.  807.3(u) of this chapter, a 
premarket notification submission for the device must include 
validation data as described in Sec.  807.3(v).
    39. Section 876.5010 is amended by revising paragraph (b) to read 
as follows:


Sec.  876.5010  Biliary catheter and accessories.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9. If the 
device is a biliary catheter that is a reprocessed single use device 
(SUD) as defined in Sec.  807.3(u) of this chapter, a premarket 
notification submission for the device must include validation data as 
described in Sec.  807.3(v).
    40. Section 876.5540 is amended in paragraph (b)(3) to read as 
follows:


Sec.  876.5540  Blood access device and accessories.

* * * * *
    (b) * * *
    (3) Class II (special controls) for accessories for both the 
implanted and the nonimplanted blood access devices not listed in 
paragraph (b)(4) of this section. If the device is a single needle 
dialysis set (coaxial flow) or fistula needle and it is a reprocessed 
single use device (SUD) as defined in Sec.  807.3(u) of this chapter, a 
premarket notification submission for the device must include 
validation data as described in Sec.  807.3(v).
* * * * *
    41. Section 876.5820 is amended by revising paragraph (b)(1) to 
read as follows:


Sec.  876.5820  Hemodialysis system and accessories.

* * * * *
    (b) Classification. (1) Class II (special controls) (for 
hemodialysis systems and all accessories directly associated with the 
extracorporeal blood system and the dialysate delivery system). If the 
device is a single needle dialysis set with uni-directional pump that 
is a reprocessed single use device (SUD) as defined in Sec.  807.3(u) 
of this chapter, a premarket notification submission for the device 
must include validation data as described in Sec.  807.3(v).
* * * * *

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    42. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


[[Page 55754]]


    43. Section 878.4200 is amended by revising paragraph (b) to read 
as follows:


Sec.  878.4200  Introduction/drainage catheter and accessories.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  878.9. If the 
device is a catheter needle that is a reprocessed single use device 
(SUD) as defined in Sec.  807.3(u) of this chapter, the exemption from 
premarket notification does not apply and the manufacturer must submit 
a premarket notification that includes validation data as described in 
Sec.  807.3(v).
    44. Section 878.4300 is amended by revising paragraph (b) to read 
as follows:


Sec.  878.4300  Implantable clip.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    45. Section 878.4400 is amended by revising paragraph (b) to read 
as follows:


Sec.  878.4400  Electrosurgical cutting and coagulation device and 
accessories.

* * * * *
    (b) Classification. Class II (special controls). If the device is 
an endoscopic or laparoscopic electrosurgical accessory that is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    46. Section 878.4750 is amended by revising paragraph (b) to read 
as follows:


Sec.  878.4750  Implantable staple.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    47. Section 878.4800 is amended by revising paragraph (b) to read 
as follows:


Sec.  878.4800  Manual surgical instrument for general use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  878.9. If the 
device is a percutaneous biopsy device, a gastroenterology-urology 
needle, a cardiovascular biopsy needle, or an aspiration and injection 
needle and it is a reprocessed single use device (SUD) as defined in 
Sec.  807.3(u) of this chapter, the exemption from premarket 
notification does not apply and the manufacturer must submit a 
premarket notification that includes validation data as described in 
Sec.  807.3(v).

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    48. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    49. Section 880.5570 is amended by revising paragraph (b) to read 
as follows:


Sec.  880.5570  Hypodermic single lumen needle.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    50. Section 880.5860 is amended by revising paragraph (b) to read 
as follows:


Sec.  880.5860  Piston syringe.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).

PART 882--NEUROLOGICAL DEVICES

    51. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    52. Section 882.4190 is amended by revising paragraph (b) to read 
as follows:


Sec.  882.4190  Clip forming/cutting instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9. If the 
device is a reprocessed single use device (SUD) as defined in Sec.  
807.3(u) of this chapter, the exemption from premarket notification 
does not apply and the manufacturer must submit a premarket 
notification that includes validation data as described in Sec.  
807.3(v).
    53. Section 882.4300 is amended by revising paragraph (b) to read 
as follows:


Sec.  882.4300  Manual cranial drills, burrs, trephines, and 
accessories.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    54. Section 882.4305 is amended by revising paragraph (b) to read 
as follows:


Sec.  882.4305  Powered compound cranial drills, burrs, trephines, and 
their accessories.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    55. Section 882.4310 is amended by revising paragraph (b) to read 
as follows:


Sec.  882.4310  Powered simple cranial drills, burrs, trephines, and 
their accessories.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    56. The authority citation for 21 CFR part 884 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    57. Section 884.1720 is amended by revising paragraph (b)(1) to 
read as follows:


Sec.  884.1720  Gynecologic laparoscope and accessories.

* * * * *
    (b) (1) Classification. Class II (special controls). If the device 
is a reprocessed single use device (SUD) as defined in Sec.  807.3(u) 
of this chapter, a premarket notification submission for the device 
must include validation data as described in Sec.  807.3(v).
* * * * *
    58. Section 884.1730 is amended by revising paragraph (b)(2) to 
read as follows:


Sec.  884.1730  Laparoscopic insufflator.

* * * * *
    (b) * * *

[[Page 55755]]

    (2) Class I for tubing and tubing/filter kits which include 
accessory instruments that are not used to effect intra-abdominal 
insufflation (pneumoperitoneum). The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in Sec.  
884.9. If the device is a reprocessed single use device (SUD) as 
defined in Sec.  807.3(u) of this chapter, the exemption from premarket 
notification does not apply and the manufacturer must submit a 
premarket notification that includes validation data as described in 
Sec.  807.3(v).
    59. Section 884.4530 is amended by revising paragraph (b)(2) to 
read as follows:


Sec.  884.4530  Obstetric-gynecologic specialized manual instrument.

* * * * *
    (b) * * *
    (2) Class I for the amniotome, uterine curette, cervical dilator 
(fixed-size bougies), cerclage needle, intrauterine device (IUD) 
remover, uterine sound, and gynecological biopsy forceps. The devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec.  884.9. If the device is a 
gynecological biopsy forceps that is a reprocessed single use device 
(SUD) as defined in Sec.  807.3(u) of this chapter, the exemption from 
premarket notification does not apply and the manufacturer must submit 
a premarket notification that includes validation data as described in 
Sec.  807.3(v).
    60. Section 884.6100 is amended by revising paragraph (b) to read 
as follows:


Sec.  884.6100  Assisted reproduction needles.

* * * * *
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, biocompatibility testing, and 
clinical testing). If the device is a reprocessed single use device 
(SUD) as defined in Sec.  807.3(u) of this chapter, the exemption from 
premarket notification does not apply and the manufacturer must submit 
a premarket notification that includes validation data as described in 
Sec.  807.3(v).

PART 886--OPTHALMIC DEVICES

    61. The authority citation for 21 CFR part 886 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    62. Section 886.4350 is amended by revising paragraph (b) to read 
as follows:


Sec.  886.4350  Manual ophthalmic surgical instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec.  886.9. If the 
device is an ophthalmic knife that is a reprocessed single use device 
(SUD) as defined in Sec.  807.3(u) of this chapter, the exemption from 
premarket notification does not apply and the manufacturer must submit 
a premarket notification that includes validation data as described in 
Sec.  807.3(v).
    63. Section 886.4370 is amended by revising paragraph (b) to read 
as follows:


Sec.  886.4370  Keratome.

* * * * *
    (b) Classification. Class I (general controls). If the device is a 
reprocessed single use device (SUD) as defined in Sec.  807.3(u) of 
this chapter, a premarket notification submission for the device must 
include validation data as described in Sec.  807.3(v).
    64. Section 886.4670 is amended by revising paragraph (b) to read 
as follows:


Sec.  886.4670  Phacofragmentation system.

* * * * *
    (b) Classification. Class II (special controls). If the device is a 
phacoemulsification needle that is a reprocessed single use device 
(SUD) as defined in Sec.  807.3(u) of this chapter, a premarket 
notification submission for the device must include validation data as 
described in Sec.  807.3(v).

PART 892--RADIOLOGY DEVICES

    65. The authority citation for 21 CFR part 892 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    66. Section 892.5730 is amended by revising paragraph (b) to read 
as follows:


Sec.  892.5730  Radionuclide brachytherapy source.

* * * * *
    (b) Classification. Class II (special controls). If the device is 
an isotope needle that is a reprocessed single use device (SUD) as 
defined in Sec.  807.3(u) of this chapter, a premarket notification 
submission for the device must include validation data as described in 
Sec.  807.3(v).

    Dated: September 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8165 Filed 9-22-06; 8:45 am]
BILLING CODE 4160-01-S