Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data, 55729-55737 [06-8166]

Agencies

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

[Federal Register Volume 71, Number 185 (Monday, September 25, 2006)]
[Rules and Regulations]
[Pages 55729-55737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8166]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending 
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 the Medical Device User Fee and Modernization Act of 
2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of 
the Federal Register, we are publishing a companion proposed rule, 
under FDA's usual procedures for notice and comment, to provide a 
procedural framework to finalize the rule in the event we receive any 
significant adverse comment and withdraw the direct final rule. This 
action codifies actions taken in previous Federal Register notices in 
accordance with MDUFMA.

DATES: This rule is effective February 7, 2007. Submit written or 
electronic comments by December 11, 2006. If we receive no significant 
adverse comments within the specified comment period, we intend to 
publish a document confirming the effective date of the final rule in 
the Federal Register within 30 days after the comment period on this 
direct final rule ends. If we receive any timely significant adverse 
comment, we will withdraw this final rule in part or in whole by 
publication of a document in the Federal Register within 30 days after 
the comment period ends.

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.

[[Page 55730]]

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. 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. According to this provision, in order to ensure that 
reprocessed SUDs are substantially equivalent to predicate devices, 
510(k)s for certain reprocessed SUDs identified by FDA must include 
validation data. These 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 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

[[Page 55731]]

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 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.

II. What Does This Direct Final Rulemaking Do?

    In this final rule, FDA is:
     Amending Sec.  807.3 to add definitions for ``single use 
device,'' ``reprocessed single use device (SUD)'' and ``validation 
data.'' The definitions of single use device and reprocessed single use 
device reflect the definitions of those terms in section 201(ll) of the 
act as amended by MDUFMA. The definition of validation data tracks the 
language used to describe validation data in section 510(o)(1)(A) of 
the act.
     Amending Sec.  807.87 (Information required in a premarket 
notification submission) to reference the requirement (of section 
510(o) of the act) to submit validation data for reprocessed SUDs in 
appropriate situations.
     Amending the classification regulations for devices for 
which FDA has revoked the exemption from premarket notification 
submission for reprocessed SUDs that require the submission of 
validation data. If the revocation applies only to a subset within a 
generic type, FDA has revised the language accordingly.
     Amending the classification regulations for devices 
already subject to premarket notification that FDA has designated as 
requiring the submission of validation data. If the requirement to 
submit validation data applies only to a subset of the generic type, 
FDA has revised the regulation accordingly.
     Making minor corrections to the classification 
regulations, including amending the sections for affected class II 
devices to update the definition of class II from requiring 
``performance standards'' to requiring ``special controls'' in order to 
provide a reasonable assurance of the safety and effectiveness of the 
device. This conforms these sections to the definition of class II at 
section 513(a)(1)(B) of the act (21 U.S.C. 360c(a)(1)(B)), as revised 
by the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629).
    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'' 
(June 1, 2004, 69 FR 30943). This guidance document may be accessed on 
the Internet at https://www.fda.gov/cdrh/ode/guidance/1216.html.

III. What are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
announced the availability of the guidance document entitled ``Guidance 
for FDA and Industry: Direct Final Rule Procedures'' that described 
when and how FDA will employ direct final rulemaking. We believe that 
this rule is appropriate for direct final rulemaking because it is 
intended to make noncontroversial amendments and minor corrections to 
existing regulations. We anticipate no significant adverse comment.
    Consistent with FDA's procedures on direct final rulemaking, we are 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule that is identical to the direct final rule. The companion 
proposed rule provides a procedural framework within which the rule may 
be finalized in the event the direct final rule is withdrawn because of 
any significant adverse comment. The comment period for this direct 
final rule runs concurrently with the comment period of the companion 
proposed rule. Any comments received in response to the companion 
proposed rule will also be considered as comments regarding this direct 
final rule.
    If we receive any significant adverse comment, we intend to 
withdraw this final rule before its effective date by publication of a 
notice in the Federal Register within 30 days after the comment period 
ends. 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 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-comment process in 
accordance with section 553 of the Administrative Procedure Act (APA) 
(5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside 
the scope of the rule will not be considered significant or 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.
    If we withdraw the direct final rule, all comments received will be 
considered under the companion proposed rule in developing a final rule 
under the usual notice-and-comment procedures under the APA (5 U.S.C. 
552a et seq.). If we receive no significant adverse comment during the 
specified comment period, we intend to publish a confirmation document 
in the Federal Register within 30 days after the comment period ends.

IV. What is the Legal Authority for This Rule?

    This direct final 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).

[[Page 55732]]

V. What is the Environmental Impact of This 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 Rule?

    We have examined the impacts of the final 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 
direct final 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 regulation only codifies in regulations 
existing statutory requirements, the agency certifies that the final 
rule 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. We do not expect this 
final 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 final 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 direct final 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 Rule?

    We have analyzed this final 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 Rule?

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

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
807, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, and 892 are 
amended as follows:

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

0
1. The authority citation for 21 CFR part 807 continues to read as 
follows:

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

0
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.

0
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

[[Page 55733]]

notification submission must include validation data as defined in 
Sec.  807.3(v).
* * * * *

PART 868--ANESTHESIOLOGY DEVICES

0
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.

0
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).

0
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).

0
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).

0
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

0
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.

0
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).

0
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).

0
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).

0
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).

0
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).

0
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).

0
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 
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).

0
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).

0
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

[[Page 55734]]

validation data as described in Sec.  807.3(v).

0
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).
* * * * *

0
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).

0
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).

0
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

0
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.

0
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).

0
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).

0
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).

0
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).

0
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

0
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.

0
31. Section 874.4140 is amended by revising paragraph (b) to read as 
follows:


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).

0
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).

0
33. Section 874.4680 is amended by revising paragraph (b) to read as 
follows:

[[Page 55735]]

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

0
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.

0
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).

0
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).
* * * * *

0
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).

0
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).

0
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).

0
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).
* * * * *

0
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

0
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.

0
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).

0
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).

0
45. Section 878.4400 is amended by revising paragraph (b) to read as 
follows:


Sec.  878.4400  Electrosurgical cutting and coagulation device and 
accessories.

* * * * *

[[Page 55736]]

    (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).

0
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).

0
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

0
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.

0
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).

0
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

0
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.

0
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).

0
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).

0
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).

0
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

0
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.

0
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).
* * * * *

0
58. Section 884.1730 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  884.1730  Laparoscopic insufflator.

* * * * *
    (b) * * *
    (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).

0
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

[[Page 55737]]

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).

0
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

0
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.

0
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).

0
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).

0
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

0
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.

0
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. 06-8166 Filed 9-22-06; 8:45 am]
BILLING CODE 4160-01-S