Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55729 

2006–19–12 Boeing: Amendment 39–14769. 

Docket No. FAA–2005–22874; 

Directorate Identifier 2005–NM–173–AD. 

Effective Date 

(a) This AD becomes effective October 30, 

2006. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Boeing Model 777–

200 and –300 series airplanes, certificated in 

any category; as identified in Boeing Special 

Attention Service Bulletin 777–54–0021, 

Revision 1, dated March 16, 2006. 

Unsafe Condition 

(d) This AD results from a report that 

several discolored fairing lower webs and 

some damaged/deteriorated insulation 

blankets were found in the aft fairings of 

engine struts. We are issuing this AD to 

prevent cracking of lower webs of the aft 

fairings, which could result in flammable 

hydraulic fluid leaking onto or near an 

ignition source, and possibly result in an 

uncontrollable fire in the engine strut area. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Inspection, Installation, and Replacement 

Actions 

(f) Except as provided by paragraph (g) of 

this AD: Within 12 months after the effective 

date of this AD, do the actions specified in 

paragraphs (f)(1), (f)(2), (f)(3), and (f)(4) of 

this AD in accordance with the 

Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 777–54–

0021, Revision 1, dated March 16, 2006. 

(1) Do a general visual inspection of the 

lower web of the aft fairing for any 

discoloration and do any related investigative 

action. 

(2) Do a general visual inspection of the 

heat shield castings for any damage (crack(s), 

dent(s), gouge(s), warpage, fretting, or 

missing/loose nutplates). 

(3) Install gap cover strips on the heat 

shield pans. 

(4) Replace insulation blankets on the heat 

shield pans with new insulation blankets. 

Repair Instructions 

(g) If any damage, discoloration, heat 

damage, or crack is found during any 

inspection required by this AD: Before 

further flight, do all applicable corrective 

actions in accordance with a method 

approved by the Manager, Seattle Aircraft 

Certification Office (ACO), FAA, or in 

accordance with the Accomplishment 

Instructions of Boeing Special Attention 

Service Bulletin 777–54–0021, Revision 1, 

dated March 16, 2006. 

Previously Accomplished Actions 

(h) Actions done before the effective date 

of this AD in accordance with Boeing Special 

Attention Service Bulletin 777–54–0021, 

dated June 23, 2005, are acceptable for 

compliance with the requirements of 

paragraph (f) of this AD, except where the 

service bulletin does not provide an 

International Annealed Copper Standard 

(ICAS) value for determining the results of 

the inspection for heat damage, the 

maximum acceptable ICAS value is 42 

percent. 

Alternative Methods of Compliance 

(AMOCs) 

(i)(1) The Manager, Seattle ACO, FAA, has 

the authority to approve AMOCs for this AD, 

if requested in accordance with the 

procedures found in 14 CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with 14 CFR 39.19 on any 

airplane to which the AMOC applies, notify 

the appropriate principal inspector in the 

FAA Flight Standards Certificate Holding 

District Office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by an 

Authorized Representative for the Boeing 

Commercial Airplanes Delegation Option 

Authorization Organization who has been 

authorized by the Manager, Seattle ACO, to 

make those findings. For a repair method to 

be approved, the repair must meet the 

certification basis of the airplane, and the 

approval must specifically refer to this AD. 

Material Incorporated by Reference 

(j) You must use Boeing Special Attention 

Service Bulletin 777–54–0021, Revision 1, 

dated March 16, 2006, to perform the actions 

that are required by this AD, unless the AD 

specifies otherwise. The Director of the 

Federal Register approved the incorporation 

by reference of this document in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

Contact Boeing Commercial Airplanes, P.O. 

Box 3707, Seattle, Washington 98124–2207, 

for a copy of this service information. You 

may review copies at the Docket Management 

Facility, U.S. Department of Transportation, 

400 Seventh Street SW., Room PL–401, 

Nassif Building, Washington, DC; on the 

Internet at http://dms.dot.gov; or at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at the NARA, 

call (202) 741–6030, or go to http:// 

www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on 

September 13, 2006. 

Kevin M. Mullin, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 06–8122 Filed 9–22–06; 8:45 am] 

BILLING CODE 4910–13–P 

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 SingleUse Devices; Requirement for 

Submission of Validation Data 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

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: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 


cprice-sewell on PROD1PC66 with RULES
55730 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 

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 email. 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 http:// 

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 http:// 

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 § 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 § 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 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55731 

in § 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 § 807.87. 

II. What Does This Direct Final 

Rulemaking Do? 

In this final rule, FDA is: 

• Amending § 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 § 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 http:// 

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). 


cprice-sewell on PROD1PC66 with RULES
55732 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 

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. 

■ 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 

■ 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. 

■ 2. Section 807.3 is amended by adding 

new paragraphs (t), (u), and (v) to read 

as follows: 

§ 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: 

§ 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 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55733 

notification submission must include 

validation data as defined in § 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: 

§ 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 § 807.3(u) of this 

chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

■ 6. Section 868.5730 is amended by 

revising paragraph (b) to read as follows: 

§ 868.5730 Tracheal tube. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 7. Section 868.5905 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

■ 8. Section 868.6810 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 868.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 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 

§ 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: 

§ 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 § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

■ 11. Section 870.1220 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 12. Section 870.1230 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1230 Fiberoptic oximeter catheter. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 13. Section 870.1280 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1280 Steerable catheter. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 14. Section 870.1290 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 15. Section 870.1330 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1330 Catheter guide wire. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 16. Section 870.1390 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

17. Section 870.1650 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 18. Section 870.1670 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 19. Section 870.2700 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 807.3(u) of this 

chapter, a premarket notification 

submission for the device must include 


cprice-sewell on PROD1PC66 with RULES
55734 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 

validation data as described in 

§ 807.3(v). 

■ 20. Section 870.3535 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

* * * * * 

■ 21. Section 870.4450 is amended by 

revising paragraph (b) to read as follows: 

§ 870.4450 Vascular clamp. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 22. Section 870.4500 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 870.9. If 

the device is a noncompression heart 

stabilizer that is a reprocessed single use 

device (SUD) as defined in § 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 

§ 807.3(v). 

■ 23. Section 870.4885 is amended by 

revising paragraph (b) to read as follows: 

§ 870.4885 External vein stripper. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 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: 

§ 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 § 872.9. If 

the device is a dental diamond coated 

bur that is a reprocessed single use 

device (SUD) as defined in § 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 

§ 807.3(v). 

■ 26. Section 872.4535 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 872.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 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 

§ 807.3(v). 

■ 27. Section 872.4730 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 872.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 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 

§ 807.3(v). 

■ 28. Section 872.5410 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 872.9. If 

the device is a orthodontic metal bracket 

that is a reprocessed single use device 

(SUD) as defined in § 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 § 807.3(v). 

■ 29. Section 872.5470 is amended by 

revising paragraph (b) to read as follows: 

§ 872.5470 Orthodontic plastic bracket. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 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 

§ 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: 

§ 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 § 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 § 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 § 807.3(v). 

■ 32. Section 874.4420 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 874.9. If 

the device is a laryngeal, sinus, or 

tracheal trocar that is a reprocessed 

single use device (SUD) as defined in 

§ 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 

§ 807.3(v). 

■ 33. Section 874.4680 is amended by 

revising paragraph (b) to read as follows: 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55735 

§ 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 § 807.3(u) of this 

chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

PART 876—GASTROENTEROLOGYUROLOGY 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: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

(2) Class I (general controls) for the 

biopsy forceps cover and the nonelectric 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 

§ 876.9. If the device is a non-electric 

biopsy forceps that is a reprocessed SUD 

as defined in § 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 § 807.3(v). 

■ 36. Section 876.1500 is amended by 

revising paragraph (b) (1) to read as 

follows: 

§ 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 § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

* * * * * 

■ 37. Section 876.4300 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

■ 38. Section 876.4680 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 876.9. If 

the device is a flexible and basket stone 

dislodger that is a reprocessed single 

use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 39. Section 876.5010 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 876.9. If 

the device is a biliary catheter that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

■ 40. Section 876.5540 is amended in 

paragraph (b) (3) to read as follows: 

§ 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 § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

* * * * * 

■ 41. Section 876.5820 is amended by 

revising paragraph (b) (1) to read as 

follows: 

§ 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 unidirectional pump that is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 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. 

■ 43. Section 878.4200 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 878.9. If 

the device is a catheter needle that is a 

reprocessed single use device (SUD) as 

defined in § 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 § 807.3(v). 

■ 44. Section 878.4300 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4300 Implantable clip. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 45. Section 878.4400 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4400 Electrosurgical cutting and 

coagulation device and accessories. 

* * * * * 


cprice-sewell on PROD1PC66 with RULES
55736 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 

(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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 46. Section 878.4750 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4750 Implantable staple. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 47. Section 878.4800 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 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 § 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 § 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: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 50. Section 880.5860 is amended by 

revising paragraph (b) to read as follows: 

§ 880.5860 Piston syringe. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 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: 

§ 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 § 882.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 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 

§ 807.3(v). 

■ 53. Section 882.4300 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 54. Section 882.4305 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 55. Section 882.4310 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 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: 

§ 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 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

* * * * * 

■ 58. Section 884.1730 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 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 

§ 884.9. If the device is a reprocessed 

single use device (SUD) as defined in 

§ 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 

§ 807.3(v). 

■ 59. Section 884.4530 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 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 § 884.9. If the device is a 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55737 

gynecological biopsy forceps that is a 

reprocessed single use device (SUD) as 

defined in § 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 § 807.3(v). 

■ 60. Section 884.6100 is amended by 

revising paragraph (b) to read as follows: 

§ 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 

§ 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 

§ 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: 

§ 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 § 886.9. If 

the device is an ophthalmic knife that 

is a reprocessed single use device (SUD) 

as defined in § 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 § 807.3(v). 

■ 63. Section 886.4370 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4370 Keratome. 

* * * * * 

(b) Classification. Class I (general 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

■ 64. Section 886.4670 is amended by 

revising paragraph (b) to read as follows: 

§ 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 § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 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: 

§ 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 § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP San Francisco Bay 06–022] 

RIN 1625–AA00 

Safety Zone; BART Transbay Tube 

Seismic Upgrade, San Francisco, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a moving temporary safety 

zone in the navigable waters of San 

Francisco Bay, California during vibro 

penetration testing for a seismic upgrade 

of the Bay Area Rapid Transit (BART) 

Transbay tube. The testing will require 

placement of a barge at test sites along 

the BART Transbay tube. The safety 

zone will surround the barge and move 

with the barge as it conducts the tests 

at seven sites along the BART Transbay 

tube. This safety zone is necessary to 

protect persons and vessels from 

hazards, injury, and damage associated 

with the vibro penetration testing. 

Unauthorized persons or vessels are 

prohibited from entering into, transiting 

through, or remaining in the safety zone 

without permission of the Captain of the 

Port or his designated representative. 

DATES: This rule is effective from 

September 25, 2006 through December 

31, 2006. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket COTP San 

Francisco Bay 06–022 and are available 

for inspection or copying at the 

Waterways Safety Branch of Sector San 

Francisco, Yerba Buena Island, Bldg. 

278, San Francisco, California, 94130, 

between 9 a.m. and 4 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Ensign Erin Bastick, U.S. Coast Guard 

Sector San Francisco, at (415) 556–2950 

or Sector San Francisco 24 hour 

Command Center at (415) 399–3547. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing an NPRM. The dates 

for the vibro penetration testing along 

the Transbay tube were not finalized 

and presented to the Coast Guard in 

time to draft and publish an NPRM. As 

such, the testing would commence 

before the rulemaking process could be 

completed. Any delay in implementing 

this rule is contrary to the public 

interest since immediate action is 

necessary in order to protect the 

maritime public from the hazards 

associated with the vibro penetration 

testing. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. The dates for the vibro 

penetration testing along the Transbay 

tube were not finalized and presented to 

the Coast Guard in time to publish this 

rule 30 days prior to its effective date. 

As such, the testing would commence 

before the rulemaking process could be 

completed. Delay in the effective date of 

this rule would expose the mariners and 

waterways users to undue hazards 

associated with the vibro penetration 

testing. 

Background and Purpose 

Bay Area Rapid Transit has contracted 

Hayward Baker, Soletanche, Traylor, A 

Joint Venture, to conduct BART marine 

demonstration tests in support of their 

earthquake safety efforts. They will be 


cprice-sewell on PROD1PC66 with RULES