Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56911 

1Spaulding, E.H., ‘‘The Role of Chemical 

Disinfection in the Prevention of Nonsocomial 

Infections,’’ P.S. Brachman and T.C. Eickof (ed), 

Proceedings of International Conference on 

Nonsocomial Infections, 1970, American Hospital 

Association, Chicago, 254-274, 1971. 

Dated: September 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19509 Filed 9–28–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003N–0161] (formerly Docket 

No. 03N–0161) 

Medical Devices; Reprocessed SingleUse Devices; Termination of 

Exemptions From Premarket 

Notification; Requirement for 

Submission of Validation Data 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is adding 

noncompression heart stabilizers to the 

list of critical reprocessed single-use 

devices (SUDs) whose exemption from 

premarket notification requirements has 

been terminated and for which 

validation data, as specified under the 

Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA), 

are necessary in a premarket notification 

(510(k)). The agency is also adding 

laparoscopic and endoscopic 

electrosurgical accessories to the list of 

reprocessed SUDs currently subject to 

premarket notification requirements that 

will now require submission of 

supplemental validation data. FDA is 

requiring submission of these data to 

ensure that reprocessed single-use 

noncompression heart stabilizers and 

laparoscopic and endoscopic 

electrosurgical accessories are 

substantially equivalent to predicate 

devices, in accordance with MDUFMA. 

DATES: These actions are effective 

September 29, 2005. Manufacturers of 

reprocessed single-use noncompression 

heart stabilizers must submit 510(k)s for 

these devices by December 29, 2006, or 

their devices may no longer be legally 

marketed. Manufacturers of reprocessed 

single-use laparoscopic and endoscopic 

electrosurgical accessories who already 

have 510(k) clearance for these devices 

must submit supplemental validation 

data for the devices by June 29, 2006, or 

their devices may no longer be legally 

marketed. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Barbara A. Zimmerman, Center for 

Devices and Radiological Health (HFZ–

410), Food and Drug Administration, 

9200 Corporate Blvd., Rockville, MD 

20850, 301–443–8320, ext. 158. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 26, 2002, MDUFMA 

(Public Law 107–250), amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding section 510(o) (21 

U.S.C. 360(o)), which provided new 

regulatory requirements for reprocessed 

SUDs. According to this new provision, 

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. 

The reprocessed SUDs subject to these 

new requirements were listed in the 

Federal Register as required by 

MDUFMA. In accordance with section 

510(o) of the act, FDA shall revise the 

lists as appropriate. This notice adds 

two types of reprocessed SUDs to the 

lists of devices subject to MDUFMA’s 

data submission requirements. 

Noncompression heart stabilizers are 

being added to the list of previously 

exempt reprocessed SUDs that now 

require the submission of 510(k)s 

containing validation data. 

Laparoscopic and endoscopic 

electrosurgical accessories are being 

added to the list of reprocessed SUDs, 

already subject to premarket notification 

requirements, for which supplemental 

validation data are required. 

A. Definitions 

Under section 302(b) of MDUFMA, a 

reprocessed SUD is defined as an 

‘‘original device that has previously 

been used on a patient and has been 

subjected to additional processing and 

manufacturing for the purpose of an 

additional single use on a patient. The 

subsequent processing and manufacture 

of a reprocessed single-use device shall 

result in a device that is reprocessed 

within the meaning of this definition.’’

Reprocessed SUDs are divided into 

three groups: (1) critical, (2) 

semicritical, and (3) noncritical. The 

first two categories reflect definitions set 

forth in MDUFMA, and all three reflect 

a classification scheme recognized in 

the industry.1 These categories of 

devices are defined as follows: 

(1) A critical reprocessed SUD is 

intended to contact normally sterile 

tissue or body spaces during use. 

(2) A semicritical reprocessed SUD is 

intended to contact intact mucous 

membranes and not penetrate normally 

sterile areas of the body. 

(3) A noncritical reprocessed SUD is 

intended to make topical contact and 

not penetrate intact skin. 

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. By April 26, 2003, 

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). 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 

56912 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

2This scheme is described in the February 2000 

draft guidance document entitled, ‘‘Reprocessing 

and Reuse of Single-Use Devices: Review 

Prioritization Scheme.’’ http://www.fda.gov/cdrh/ 

reuse/1156.html. 

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. On June 26, 2003 (68 FR 

38071), FDA recategorized nine device 

types from semicritical to critical, and 

added nonelectric gastroenterologyurology biopsy forceps to the list of 

critical devices whose exemption from 

premarket notification requirements was 

being terminated. 

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). 

As discussed above, 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, 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 on April 

30, 2003 (68 FR 23139). As described 

above, FDA must revise the list of 

devices subject to this requirement as 

appropriate. 

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 including validation data 

regarding cleaning, sterilization, and 

functional performance, in addition to 

all the other required elements 

identified in 21 CFR 807.87, in order to 

market these devices. 

II. FDA’s Implementation of New 

Section 510(o) of the Act 

In the Federal Register of April 30, 

2003 (68 FR 23139), FDA described the 

methodology and criteria used to 

identify the reprocessed SUDs that were 

included in the lists required by 

MDUFMA. First, FDA described how it 

identified the types of SUDs currently 

being reprocessed and how the 

Spaulding definitions (see footnote 1) 

were used to categorize these devices as 

critical, semicritical, or noncritical. (See 

Attachment 1.) Next, the agency 

described its use of the Risk 

Prioritization Scheme (RPS)2 that was 

used to evaluate the potential risk (high, 

moderate, or low) associated with an 

SUD based on the following factors: (1) 

Risk of infection and (2) risk of 

inadequate performance following 

reprocessing. FDA identified its final 

criterion as those reprocessed SUDs 

intended to come in contact with tissue 

at high risk of being infected with the 

causative agents of Creutzfeldt-Jakob 

Disease (CJD). (These are generally 

devices intended for use in 

neurosurgery and ophthalmology.) 

Using this methodology and these 

criteria, the devices included on List I 

(Critical and Semicritical Reprocessed 

SUDs Previously Exempt from 

Premarket Notification Requirements 

that Now Require 510(k)s with 

Validation Data) of the April 30, 2003, 

June 26, 2003, and April 13, 2004, 

Federal Register notices are those 

critical and semicritical reprocessed 

SUDs that were either high risk 

according to the RPS or intended to 

come in contact with tissue at high risk 

of being infected with CJD. The devices 

included on List II (Reprocessed SUDs 

Subject to Premarket Notification 

Requirements that Now Require the 

Submission of Validation Data) of the 

April 30, 2003, Federal Register notice 

are those reprocessed SUDs already 

subject to premarket notification 

requirements that were either high risk 

according to the RPS or intended to 

come in contact with tissue at high risk 

of being infected with CJD. 

III. Revisions to Attachment 1, List I, 

and List II 

A. Revisions to Attachment 1 (List of 

SUDs Known To Be Reprocessed or 

Considered for Reprocessing) 

FDA has evaluated the comments 

received regarding section 510(o) of the 

act. In doing so, the agency has 

determined that all noncompression 

heart stabilizers and endoscopic and 

laparoscopic electrosurgical accessories 

should be considered high risk devices 

when reprocessed. 

Noncompression heart stabilizers are 

intended to move, lift, and position the 

heart while maintaining hemodynamic 

stability during cardiovascular surgery. 

The agency has determined that 

noncompression heart stabilizers are 

high risk devices when reprocessed 

because they include features, such as 

narrow tubing, interlocking parts, and 

small crevices that could impede 

cleaning and sterilization and because 

these devices contain materials, 

coatings, or components that may be 

damaged or altered by reprocessing. 

Therefore, these devices have the 

potential for a high risk of infection 

and/or inadequate performance when 

reprocessed. This includes 

noncompression heart stabilizers 

(device 21 in Attachment 1) classified 

under § 870.4500 (21 CFR 870.4500). In 

determining that noncompression heart 

stabilizers are high risk devices when 

reprocessed, a new product code has 

been created to identify these devices 

within regulation § 870.4500. The new 

product code is NQG. This new product 

code has been added to device 21 in 

Attachment 1 of this document. 

Endoscopic and laparoscopic 

electrosurgical accessories are surgical 

instruments used during minimally 

invasive surgery, including vein 

harvesting. The agency has determined 

that these devices should be considered 

high risk devices when reprocessed 

because they include features, such as 

narrow lumens, that could impede 

thorough cleaning and sterilization and 

because these devices contain materials, 

coatings, or components that may be 

damaged or altered by reprocessing. 

Therefore, these devices have the 

potential for a high risk of infection or 

inadequate performance when 

reprocessed. This includes endoscopic 

and laparoscopic electrosurgical 

accessories (device 162 in Attachment 

1) classified under § 878.4400 (21 CFR 

878.4400). In determining that 

endoscopic and laparoscopic 

electrosurgical accessories are 

potentially high risk devices when 

reprocessed, a new product code has 

been created to identify these devices 

within regulation § 878.4400. The new 

product code is NUJ. This new product 

code has been added to device 162 in 

Attachment 1. 

These changes are reflected in a 

revised version of Attachment 1 

included in this Federal Register notice. 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56913 

B. Revisions to List I (Critical and 

Semicritical Reprocessed Single-Use 

Devices Previously Exempt from 

Premarket Notification Requirements 

that Now Require 510(k)s with 

Validation Data) 

Using the RPS, FDA has recategorized 

noncompression heart stabilizers from 

moderate risk to high risk when 

reprocessed, and the agency has 

therefore added noncompression heart 

stabilizers to List I. Manufacturers of 

noncompression heart stabilizers will be 

required to submit 510(k)s with 

validation data by December 29, 2006, 

which is 15 months following this 

revision of the list. 

To help reprocessors be able to easily 

identify those critical and semicritical 

reprocessed SUDs that have been 

categorized into List I in this notice and 

previous Federal Register notices, FDA 

is re-issuing a complete listing of these 

devices. Therefore, List 1 now identifies 

all critical and semicritical reprocessed 

SUDs previously exempt from 

premarket notification requirements that 

now require 510(k)s with validation 

data. 

C. Revisions to List II (Reprocessed 

Single-Use Devices Subject to Premarket 

Notification Requirements that Now 

Require the Submission of Validation 

Data) 

Using the RPS, FDA has recategorized 

endoscopic and laparoscopic 

electrosurgical accessories under 

regulation § 878.4400 from moderate 

risk to high risk when reprocessed. 

Therefore, endoscopic and laparoscopic 

electrosurgical accessories have been 

added to List II. Under MDUFMA, 

manufacturers of these devices who 

have already obtained clearance through 

the 510(k) process must submit 

validation data regarding cleaning, 

sterilization, and functional 

performance by June 29, 2006, which is 

9 months following this revision of the 

list. Upon publication of this notice, 

manufacturers who have not yet 

obtained clearance through the 510(k) 

process must submit 510(k)s including 

validation data regarding cleaning, 

sterilization, and functional 

performance, in addition to all the other 

required elements of a 510(k) identified 

in 21 CFR 807.87, in order to market 

these devices. 

LIST I.—CRITICAL AND SEMICRITICAL REPROCESSED SINGLE-USE DEVICES PREVIOUSLY EXEMPT FROM PREMARKET NOTIFICATION REQUIREMENTS THAT NOW REQUIRE 510(K)S WITH VALIDATION DATA [MANUFACTURERS OF NONCOMPRESSION HEART STABILIZERS WILL NEED TO SUBMIT 510(K)S WITH VALIDATION DATA BY 15 MONTHS FOLLOWING THE PUBLICATION OF THIS REVISED LIST.] 

21 CFR No. Classification name 

Product code for nonreprocessed 

device 

Product code for 

reprocessed 

device 

Product code name for 

reprocessed device 

868.6810 Tracheobronchial suction catheter BSY NQV Tracheobronchial suction catheter 

870.4500 Cardiovascular surgical instruments MWS NQG Noncompression heart stabilizer 

872.3240 Dental bur Diamond coated NME Dental diamond coated bur 

872.4535 Dental diamond instrument DZP NLD Dental diamond instrument 

872.4730 Dental injection needle DZM NMW Dental needle 

872.5410 Orthodontic appliance and accessories EJF NQS Orthodontic metal bracket 

874.4140 Ear, nose, and throat bur Microdebrider NLY ENT high speed microdebrider 

874.4140 Ear, nose, and throat bur Diamond coated NLZ ENT diamond coated bur 

874.4420 Ear, nose, throat manual surgical .. KAB, KBG, KCI NLB Laryngeal, sinus, tracheal trocar 

876.1075 Gastroenterology-urology biopsy instrument FCL NON Nonelectric biopsy forceps 

876.4680 Ureteral stone dislodger FGO, FFL NQT, NQU Flexible and basket stone 

dislodger 

878.4200 Introduction/drainage catheter and accessories GCB NMT Catheter needle 

878.4800 Manual surgical instrument MJG NNA Percutaneous biopsy device 

878.4800 Manual surgical instrument FHR NMU Gastro-Urology needle 

878.4800 Manual surgical instrument for ... .... DWO NLK Cardiovascular biopsy needle 

878.4800 Manual surgical instrument for... GAA NNC Aspiration and injection needle 

882.4190 Forming/cutting clip instrument HBS NMN Forming/cutting clip instrument 

884.1730 Laparoscopic insufflator, .. HIF NMI Laparoscopic insufflator and accessories 

884.4530 OB/GYN specialized manual instrument HFB NMG Gynecological biopsy forceps 

886.4350 Manual ophthalmic surgical instrument HNN NLA Ophthalmic knife 

56914 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

LIST II.—REPROCESSED SINGLE-USE DEVICES SUBJECT TO PREMARKET NOTIFICATION REQUIREMENTS THAT NOW REQUIRE THE SUBMISSION OF VALIDATION DATA1 [MANUFACTURERS OF ENDOSCOPIC AND LAPAROSCOPIC

ELECTROSURGICAL ACCESSORIES WHO ALREADY HAVE 510(K) CLEARANCE FOR THESE DEVICES MUST SUBMIT VALIDATION DATA BY JUNE 29, 2006. ANY NEW 510(K) FOR THIS DEVICE TYPE WILL REQUIRE VALIDATION DATA UPON PUBLICATION OF THIS DOCUMENT.] 

21 CFR No. Classification name 

Product code for 

nonreprocessed 

device 

Product code for 

reprocessed 

device 

Product code name for 

reprocessed device 

Unclassified Oocyte aspiration needles MHK NMO Oocyte aspiration needles 

Unclassified Percutaneous transluminal angioplasty catheter LIT NMM Transluminal peripheral 

angioplasty catheter 

Unclassified Ultrasonic surgical instrument LFL NLQ Ultrasonic scalpel 

868.5150 Anesthesia conduction needle BSP NNH Anesthetic conduction needle 

(with/without introducer) 

868.5150 Anesthesia conduction needle MIA NMR Short term spinal needle 

868.5730 Tracheal tube BTR NMA Tracheal tube (with/without connector) 

868.5905 Noncontinuous ventilator (IPPB) BZD NMC Noncontinuous ventilator (respirator) mask 

870.1200 Diagnostic intravascular catheter DQO NLI Angiography catheter 

870.1220 Electrode Recording Catheter DRF NLH Electrode recording catheter 

870.1220 Electrode Recording Catheter MTD NLG Intracardiac mapping catheter 

870.1230 Fiberoptic oximeter catheter DQE NMB Fiberoptic oximeter catheter 

870.1280 Steerable Catheter DRA NKS Steerable Catheter 

870.1290 Steerable catheter control system DXX NKR Steerable catheter control system 

870.1330 Catheter guide wire DQX NKQ Catheter guide wire 

870.1390 Trocar DRC NMK Cardiovascular trocar 

870.1650 Angiographic injector and syringe DXT NKT Angiographic injector and syringe 

870.1670 Syringe actuator for injector DQF NKW Injector for actuator syringe 

870.2700 Oximeter MUD NMD Tissue saturation oximeter 

870.2700 Oximeter DQA NLF Oximeter 

870.3535 Intra-aortic balloon and control system DSP NKO Intra-aortic balloon and control 

system 

870.4450 Vascular clamp DXC NMF Vascular clamp 

870.4885 External vein stripper DWQ NLJ External vein stripper 

872.5470 Orthodontic Plastic Bracket DYW NLC Orthodontic Plastic Bracket 

874.4680 Bronchoscope (flexible or rigid) and accessories BWH NLE Bronchoscope (nonrigid) biopsy 

forceps 

876.1075 Gastro-Urology biopsy instrument FCG NMX G-U biopsy needle and needle 

set 

876.1075 Gastroenterology-urology biopsy instrument KNW NLS Biopsy instrument 

876.1500 Endoscope and accessories FBK, FHP NMY Endoscopic needle 

876.1500 Endoscope and accessories MPA NKZ Endoilluminator 

876.1500 Endoscope and accessories GCJ NLM General and plastic surgery 

laparoscope 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56915 

LIST II.—REPROCESSED SINGLE-USE DEVICES SUBJECT TO PREMARKET NOTIFICATION REQUIREMENTS THAT NOW REQUIRE THE SUBMISSION OF VALIDATION DATA1 [MANUFACTURERS OF ENDOSCOPIC AND LAPAROSCOPIC

ELECTROSURGICAL ACCESSORIES WHO ALREADY HAVE 510(K) CLEARANCE FOR THESE DEVICES MUST SUBMIT VALIDATION DATA BY JUNE 29, 2006. ANY NEW 510(K) FOR THIS DEVICE TYPE WILL REQUIRE VALIDATION DATA UPON PUBLICATION OF THIS DOCUMENT.]—Continued 

21 CFR No. Classification name 

Product code for 

nonreprocessed 

device 

Product code for 

reprocessed 

device 

Product code name for 

reprocessed device 

876.1500 Endoscope and accessories FHO NLX Spring-loaded 

pneumoperitoneum needle 

876.4300 Endoscopic electrosurgical unit and accessories FAS NLW Active Urological electrosurgical 

electrode 

876.4300 Endoscopic electrosurgical unit and accessories FEH NLV Flexible suction coagulator electrode 

876.4300 Endoscopic electrosurgical unit and accessories KGE NLU Electric biopsy forceps 

876.4300 Endoscopic electrosurgical unit and accessories FDI NLT Flexible snare 

876.4300 Endoscopic electrosurgical unit and accessories KNS NLR Endoscopic (with or without accessories) Electrosurgical unit 

876.5010 Biliary catheter and accessories FGE NML Biliary catheter 

876.5540 Blood access device and accessories LBW NNF Single needle dialysis set (coaxial flow) 

876.5540 Blood access device and accessories FIE NNE Fistula needle 

876.5820 Hemodialysis systems and accessories FIF NNG Single needle dialysis set with 

uni-directional pump 

878.4300 Implantable clip FZP NMJ Implantable clip 

878.4400 Electrosurgical Cutting and Coagulation Device and Accessories GEI NUJ Endoscopic and laparoscopic 

electrosurgical accessories 

878.4750 Implantable staple GDW NLL Implantable staple 

880.5570 Hypodermic single lumen needle FMI NKK Hypodermic single lumen needle 

880.5860 Piston Syringe FMF NKN Piston Syringe 

882.4300 Manual cranial drills, burrs, trephines and 

accessories 

HBG NLO (Manual) drills, burrs, trephines 

and accessories 

882.4305 Powered compound cranial drills, burrs, 

trephines . 

HBF NLP (Powered, compound) drills, 

burrs, trephines and accessories 

882.4310 Powered simple cranial drills, burrs, 

trephines . 

HBE NLN (Simple, powered) drills, burrs, 

trephines and accessories 

884.1720 Gynecologic laparoscope and accessories HET NMH Gynecologic laparoscope (and 

accessories) 

884.6100 Assisted reproduction needle MQE NNB Assisted reproduction needle 

886.4370 Keratome HMY, HNO NKY Keratome blade 

886.4670 Phacofragmentation system HQC NKX Phacoemulsification needle 

892.5730 Radionuclide brachytherapy source IWF NMP Isotope needle 

1Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in ‘‘Draft Guidance for Hemodialyzer 

Reuse Labeling’’ October 6, 1995. An archived copy may be obtained from CDRH’s Division of Small Manufacturers, International, and Consumer Assistance, please contact dsmica@cdrh.fda.gov. 

56916 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

IV. Stakeholder Input 

In the Federal Register of February 4, 

2003 (68 FR 5643), FDA invited 

interested persons to provide 

information and share views on the 

implementation of MDUFMA. Since 

that time, the agency has received 

comments on various MDUFMA 

provisions, including several on its 

implementation of section 510(o) of the 

act. As discussed above, one comment 

recommended that heart stabilizers 

should be considered high risk because 

of the risk of cross contamination and 

deterioration of the mechanical 

properties of the device. FDA agrees that 

noncompression heart stabilizers, a 

subset of all heart stabilizers, should be 

added to the list of critical reprocessed 

SUDs previously exempt from 

premarket notification requirements that 

will now require 510(k)s with validation 

data. Therefore, FDA has added 

noncompression heart stabilizers to List 

I. 

Another comment recommended that 

FDA recategorize endoscopic vessel 

harvesting devices as high risk to be 

consistent with the categorization of 

other endoscopic accessories under 21 

CFR 876.1500 (Endoscope and 

accessories). FDA agrees that 

endoscopic vessel harvesting devices 

should be considered high risk and 

subject to the submission of validation 

data. As discussed previously, in 

reviewing this comment, the agency also 

determined that laparoscopic 

electrosurgical accessories should be 

similarly categorized. Therefore, FDA 

has added laparoscopic and endoscopic 

electrosurgical accessories to List II. 

Other additional comments requested 

that specific reprocessed SUDs be added 

to either List I or II. Each of these 

comments was carefully considered. 

However, FDA does not believe, based 

on the risk-based approach described in 

the April 30, 2003, Federal Register 

notice, that SUDs other than those 

identified in this notice should be 

added to the Lists at this time. 

Another comment requested the FDA 

to call for the immediate submission 

and review of validation data regarding 

cleaning, sterilization, and functional 

performance for all reprocessed SUDs. 

The comment further stated that this 

request was based on the significant 

number of reprocessed devices which 

were withdrawn or were deemed to be 

insufficiently supported by validation 

data as of February 8, 2005. 

Section 510(o) of the act required FDA 

to identify those reprocessed SUDs for 

which validation data must be 

submitted in order to ensure that those 

SUDs remain substantially equivalent to 

predicate devices after reprocessing. 

Because the agency has found that some 

reprocessed SUDs do not require the 

submission and review of validation 

data in order to demonstrate substantial 

equivalence, the agency identified the 

types of devices requiring the 

submission of validation data by 

implementing a risk-based approach. 

This risk-based approach, described in 

the April 30, 2003, Federal Register 

notice, identified a significant number 

of reprocessed SUDs that can no longer 

be legally marketed without agency 

review and clearance of validation data. 

The failure of some manufacturers to 

submit this validation data and the 

agency’s review of submitted data 

resulted in a determination that a 

significant number of reprocessed SUDs 

could no longer be legally marketed. 

However, the process also identified a 

significant number of reprocessed SUDs 

that could continue to be marketed 

because: (1) they were found not to 

require the submission of additional 

validation data in order to ensure 

substantial equivalence to legally 

marketed predicate devices; or (2) after 

a review of submitted validation data, 

they were found to be substantially 

equivalent to legally marketed predicate 

devices. Therefore, FDA does not intend 

to expand the list of reprocessed SUDs 

subject to the submission and review of 

validation data to all reprocessed SUDs 

as requested in the comment. The 

agency believes it has implemented 

section 510(o) of the act by identifying 

the types of devices that require the 

submission of validation data and 

determining which of those devices can 

no longer be legally marketed. 

V. Comments 

You may submit written or electronic 

comments on the designation of 

reprocessed noncompression heart 

stabilizers and laparoscopic and 

endoscopic electrosurgical devices 

requiring the submission of premarket 

notifications with validation data to the 

Division of Dockets Management (see 

ADDRESSES). Submit electronic 

comments to http://www.fda.gov/ 

dockets/ecomments. Submit two copies 

of mailed comments, but individuals 

may submit one copy. You should 

identify your comments with the docket 

number found in brackets in the 

heading of this document. You may see 

any comments FDA receives in the 

Dockets Management Branch between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

1 Cardio Cardiopulmonary Bypass 

Marker 

Unclassified MAB 1 C N 

2 Cardio Percutaneous & Operative 

Transluminal Coronary 

Angioplasty Catheter 

(PTCA) 

Post-amendment III LOX 3 C N 

3 Cardio Percutaneous Ablation 

Electrode 

Post-amendment III LPB 3 C N 

4 Cardio Peripheral Transluminal 

Angioplasty (PTA) Catheter 

870.1250 II LIT 3 C N 

5 Cardio Blood-Pressure Cuff 870.1120 II DXQ 1 N N 

6 Cardio Angiography Catheter 870.1200 II DQO 3 C N 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56917 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

7 Cardio Electrode Recording Catheter 870.1220 II DRF 3 C N 

8 Cardio High-Density Array Catheter 870.1220 II MTD 3 C N 

9 Cardio Fiberoptic Oximeter Catheter 870.1230 II DQE 3 C N 

10 Cardio Steerable Catheter 870.1280 II DRA 3 C N 

11 Cardio Steerable Catheter Control 

System 

870.1290 II DXX 3 C N 

12 Cardio Guide Wire 870.1330 II DQX 3 C N 

13 Cardio Angiographic Needle 870.1390 II DRC 3 C N 

14 Cardio Trocar 870.1390 II DRC 3 C N 

15 Cardio Syringes 870.1650 II DXT 3 C N 

16 Cardio Injector Type Syringe Actuator 870.1670 II DQF 3 C N 

17 Cardio Oximeter 870.2700 II DQA 3 N N 

18 Cardio Tissue Saturation Oximeter 870.2700 II MUD 3 C N 

19 Cardio Intra-Aortic Balloon System 870.3535 III DSP 3 C N 

20 Cardio Vascular Clamp 870.4450 II DXC 3 C N 

21 Cardio Heart Stabilizer 870.4500 I MWS 2 C Y 

22 Cardio Noncompression Heart 

Stabilizer 

870.4500 I MWS 3 C Y 

23 Cardio External Vein Stripper 870.4885 II DWQ 3 C N 

24 Cardio Compressible Limb Sleeve 870.5800 II JOW 1 N N 

25 Dental Bur 872.3240 I EJL 1 C Y 

26 Dental Diamond Coated Bur 872.3240 I EJL 3 C Y 

27 Dental Diamond Instrument 872.4535 I DZP 3 C Y 

28 Dental AC-Powered Bone Saw 872.4120 II DZH 2 C N 

29 Dental Manual Bone Drill and 

Wire Driver 

872.4120 II DZJ 2 C N 

30 Dental Powered Bone Drill 872.4120 II DZI 2 C N 

31 Dental Intraoral Drill 872.4130 I DZA 1 C Y 

32 Dental Injection needle 872.4730 I DZM 3 C Y 

33 Dental Metal Orthodontic Bracket 872.5410 I EJF 3 S Y 

34 Dental Plastic Orthodontic Bracket 872.5470 II DYW 3 S N 

35 ENT Bur 874.4140 I EQJ 1 C Y 

36 ENT Diamond Coated Bur 874.4140 I EQJ 3 C Y 

37 ENT Microdebrider 874.4140 I EQJ 3 C Y 

56918 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

38 ENT Microsurgical Argon Fiber 

Optic Laser Cable, For 

Uses Other Than 

Otology, Including Laryngology & General Use 

In Otolaryngology 

874.4490 II LMS 1 S N 

39 ENT Microsurgical Argon Fiber 

Optic Laser Cable, For 

Use In Otology 

874.4490 II LXR 1 S N 

40 ENT Microsurgical Carbon-Dioxide Fiber Optic Laser 

Cable 

874.4500 II EWG 1 S N 

41 ENT Bronchoscope Biopsy Forceps (Nonrigid) 874.4680 II BWH 3 C N 

42 ENT Bronchoscope Biopsy Forceps (Rigid) 874.4680 II JEK 1 C N 

43 Gastro/ Urology Biopsy Forceps Cover 876.1075 I FFF 1 C Y 

44 Gastro/ Urology Biopsy Instrument 876.1075 II KNW 3 C N 

45 Gastro/ Urology Biopsy Needle Set 876.1075 II FCG 3 C N 

46 Gastro/ Urology Biopsy Punch 876.1075 II FCI 2 C N 

47 Gastro/ Urology Mechanical Biopsy Instrument 876.1075 II FCF 2 C N 

48 Gastro/ Urology Nonelectric Biopsy Forceps 876.1075 I FCL 3 C Y 

49 Gastro/ Urology Cytology Brush For Endoscope 876.1500 II FDX 2 S N 

50 Gastro/ Urology Endoscope accessories 876.1500 II KOG 2 S N 

51 Gastro/ Urology Extraction Balloons/Baskets 876.1500 II KOG 2 S N 

52 Gastro/Urology Endoscopic needle 876.1500 II FBK 3 C N 

53 Gastro/ Urology Simple Pneumoperitoneum 

Needle 

876.1500 II FHP 3 C N 

54 Gastro/ Urology Spring Loaded 

Pneumoperitoneum 

Needle 

876.1500 II FHO 3 C N 

55 Gastro/ Urology Active Electrosurgical 

Electrode 

876.4300 II FAS 3 S N 

56 Gastro/ Urology Biliary Sphincterotomes 876.5010, 

876.1500 

II FGE 3 C N 

57 Gastro/ Urology Electric Biopsy Forceps 876.4300 II KGE 3 C N 

58 Gastro/ Urology Electrosurgical Endoscopic 

Unit (With Or Without 

Accessories) 

876.4300 II KNS 3 S N 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56919 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

59 Gastro/ Urology Flexible Snare 876.4300 II FDI 3 S N 

60 Gastro/ Urology Flexible Suction Coagulator Electrode 876.4300 II FEH 3 S N 

61 Gastro/ Urology Flexible Stone Dislodger 876.4680 II FGO 3 S Y 

62 Gastro/ Urology Metal Stone Dislodger 876.4680 II FFL 3 S Y 

63 Gastro/ Urology Needle Holder 876.4730 I FHQ 1 C Y 

64 Gastro/ Urology Nonelectrical Snare 876.4730 I FGX 1 S Y 

65 Gastro/ Urology Urological Catheter 876.5130 II KOD 2 S N 

66 Gastro/Urology Single needle dialysis set 876.5540 II LBW, FIE 3 C N 

67 Gastro/ Urology Hemodialysis Blood Circuit 

Accessories 

876.5820 II KOC 2 S N 

68 Gastro/Urology Single needle dialysis set 876.5820 II FIF 3 C N 

69 Gastro/Urology Hemorrhoidal Ligator 876.4400 II FHN 2 C N 

70 General 

Hospital 

Implanted, Programmable 

Infusion Pump 

Post-amendment III LKK 3 C N 

71 General 

Hospital 

Needle Destruction Device Post-amendment III MTV 1 N N 

72 General 

Hospital 

Nonpowered Flotation 

Therapy Mattress 

880.5150 I IKY 2 N Y 

73 General 

Hospital 

NonAC-Powered Patient 

Lift 

880.5510 I FSA 2 N Y 

74 General 

Hospital 

Alternating Pressure Air 

Flotation Mattress 

880.5550 II FNM 1 N Y 

75 General 

Hospital 

Temperature Regulated 

Water Mattress 

880.5560 I FOH 2 N Y 

76 General 

Hospital 

Hypodermic Single Lumen 

Needle 

880.5570 II FMI 3 C N 

77 General 

Hospital 

Piston Syringe 880.5860 II FMF 3 C N 

78 General 

Hospital 

Mattress Cover (Medical 

Purposes) 

880.6190 I FMW 2 N Y 

79 General 

Hospital 

Disposable Medical Scissors 880.6820 I JOK 1 N Y 

80 General 

Hospital 

Irrigating Syringe 880.6960 I KYZ, KYY 1 C Y 

81 Infection 

Control 

Surgical Gowns 878.4040 II FYA 1 C N 

82 Lab Blood Lancet 878.4800 I FMK 1 C Y 

56920 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

83 Neurology Clip Forming/Cutting Instrument, 882.4190 I HBS 3* C Y 

84 Neurology Drills, Burrs, Trephines 

&Accessories (Manual) 

882.4300 II HBG 3* C N 

85 Neurology Drills, Burrs, Trephines 

&Accessories (Compound, Powered) 

882.4305 II HBF 3* C N 

86 Neurology Drills, Burrs, Trephines 

&Accessories (Simple, 

Powered) 

882.4310 II HBE 3* C N 

87 OB/GYN Oocyte aspiration needle III MHK 3 C N 

88 OB/GYN Laparoscope accessories 884.1720 I HET 2 C Y 

89 OB/GYN Laparoscope Accessories 884.1720 II HET 3 C N 

90 OB/GYN Laparoscopic Dissectors 884.1720 I HET 2 C Y 

91 OB/GYN Laparoscopic Graspers 884.1720 I HET 2 C Y 

92 OB/GYN Laparoscopic Scissors 884.1720 I HET 2 C Y 

93 OB/GYN Insufflator accessories 

(tubing, Verres needle, 

kits) 

884.1730 II HIF 3 C Y 

94 OB/GYN Laparoscopic Insufflator 884.1730 II HIF 2 N N 

95 OB/GYN Endoscopic Electrocautery 

and Accessories 

884.4100 II HIM 2 N N 

96 OB/GYN Gynecologic 

Electrocautery (and Accessories) 

884.4120 II HGI 2 N N 

97 OB/GYN Endoscopic Bipolar Coagulator-Cutter (and Accessories) 884.4150 II HIN 2 N N 

98 OB/GYN Culdoscopic Coagulator 

(and Accessories) 

884.4160 II HFI 2 N N 

99 OB/GYN Endoscopic Unipolar Coagulator-Cutter (and Accessories) 884.4160 II KNF 2 N N 

100 OB/GYN Hysteroscopic Coagulator 

(and Accessories) 

884.4160 II HFH 2 N N 

101 OB/GYN Unipolar Laparoscopic Coagulator (and Accessories) 884.4160 II HFG 2 N N 

102 OB/GYN Episiotomy Scissors 884.4520 I HDK 1 C Y 

103 OB/GYN Umbilical Scissors 884.4520 I HDJ 1 C Y 

104 OB/GYN Biopsy Forceps 884.4530 I HFB 3 C Y 

105 OB/GYN Assisted reproduction needle 884.6100 II MQE 3 C N 

106 Ophthalmic Endoilluminator 876.1500 II MPA 3* C N 

107 Ophthalmic Surgical Drapes 878.4370 II KKX 2 C N 

108 Ophthalmic Ophthalmic Knife 886.4350 I HNN 3 C Y 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56921 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

109 Ophthalmic Keratome Blade 886.4370 I HMY, HNO 3 C N 

110 Ophthalmic Phacoemulsification Needle 886.4670 II HQC 3 C N 

111 Ophthalmic Phacoemulsification/ 

Phacofragmentation 

Fluidic 

886.4670 II MUS 2 C N 

112 Ophthalmic Phacofragmentation Unit 886.4670 II HQC 1 N N 

113 Orthopedic Saw Blades 878.4820 I GFA, DWH, 

GEY, 

GET 

1 C Y 

114 Orthopedic Surgical Drills 878.4820 I GEY, GET 1 C Y 

115 Orthopedic Arthroscope accessories 888.1100 II HRX 2 C Y 

116 Orthopedic Bone Tap 888.4540 I HWX 1 C Y 

117 Orthopedic Burr 888.4540 I HTT 1 C Y 

118 Orthopedic Carpal Tunnel Blade 888.4540 I LXH 2 C Y 

119 Orthopedic Countersink 888.4540 I HWW 1 C Y 

120 Orthopedic Drill Bit 888.4540 I HTW 1 C Y 

121 Orthopedic Knife 888.4540 I HTS 1 C Y 

122 Orthopedic Manual Surgical Instrument 888.4540 I LXH 1 C Y 

123 Orthopedic Needle Holder 888.4540 I HXK 1 C Y 

124 Orthopedic Reamer 888.4540 I HTO 1 C Y 

125 Orthopedic Rongeur 888.4540 I HTX 1 C Y 

126 Orthopedic Scissors 888.4540 I HRR 1 C Y 

127 Orthopedic Staple Driver 888.4540 I HXJ 1 C Y 

128 Orthopedic Trephine 888.4540 I HWK 1 C Y 

129 Orthopedic Flexible Reamers/Drills 886.4070 

878.4820 

I GEY, HRG 1 C Y 

130 Orthopedic External Fixation Frame 888.3040 

888.3030 

II JEC KTW 

KTT 

2 N N 

131 Physical 

Medicine 

Nonheating Lamp for Adjunctive Use Inpatient 

Therapy 

890.5500 II NHN 1 N N 

132 Physical 

Medicine 

Electrode Cable, 890.1175 II IKD 1 N Y 

133 Physical 

Medicine 

External Limb Component, 

Hip Joint 

890.3420 I ISL 2 N Y 

134 Physical 

Medicine 

External Limb Component, 

Knee Joint 

890.3420 I ISY 2 N Y 

135 Physical 

Medicine 

External Limb Component, 

Mechanical Wrist 

890.3420 I ISZ 2 N Y 

136 Physical 

Medicine 

External Limb Component, 

Shoulder Joint 

890.3420 I IQQ 2 N Y 

56922 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

137 Plastic Surgery Stapler 878.4800 I GAG, GEF, 

FHM, 

HBT 

2 C Y 

138 Radiology Isotope Needle 892.5730 II IWF 3 C N 

139 Respiratory Endotracheal Tube Changer Unclassified III LNZ 3 C N 

140 Respiratory Anesthesia conduction 

needle 

868.5150 II BSP 3 C N 

141 Respiratory Short term spinal needle 868.5150 II MIA 3 C N 

142 Respiratory Respiratory Therapy and 

Anesthesia Breathing 

Circuits 

868.5240 I CAI 2 S Y 

143 Respiratory Oral and Nasal Catheters 868.5350 I BZB 1 C Y 

144 Respiratory Gas Masks 868.5550 I BSJ 1 S Y 

145 Respiratory Breathing Mouthpiece 868.5620 I BYP 1 N Y 

146 Respiratory Tracheal Tube 868.5730 II BTR 3 C N 

147 Respiratory Airway Connector 868.5810 I BZA 2 S Y 

148 Respiratory CPAP Mask 868.5905 II BZD 3 S N 

149 Respiratory Emergency Manual Resuscitator 868.5915 II BTM 2 S N 

150 Respiratory Tracheobronchial Suction 

Catheter 

868.6810 I BSY 3 S Y 

151 Surgery AC-powered Orthopedic 

Instrument and accessories 

878.4820 I HWE 2 C N 

152 Surgery Breast Implant Mammary 

Sizer 

Unclassified MRD 1 C N 

153 Surgery Ultrasonic Surgical Instrument Unclassified LFL 3 C N 

154 Surgery Trocar 874.4420 I KAB, KBG, 

KCI 

3 C Y 

155 Surgery Endoscopic Blades 876.1500 II GCP, GCR 2 C N 

156 Surgery Endoscopic Guidewires 876.1500 II GCP, GCR 1 C N 

157 Surgery Inflatable External Extremity Splint 878.3900 I FZF 1 N Y 

158 Surgery Noninflatable External Extremity Splint 878.3910 I FYH 1 N Y 

159 Surgery Catheter needle 878.4200 I GCB 3 C Y 

160 Surgery Implantable Clip 878.4300 II FZP 3 C N 

161 Surgery Electrosurgical and Coagulation Unit With Accessories 878.4400 II BWA 2 C N 

162 Surgery Electrosurgical Apparatus 878.4400 II HAM 2 C N 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56923 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

163 Surgery Electrosurgical Cutting & 

Coagulation Device & 

Accessories 

878.4400 II GEI 

NUJ 

2 

3 

C N 

164 Surgery Electrosurgical Device 878.4400 II DWG 2 C N 

165 Surgery Electrosurgical Electrode 878.4400 II JOS 2 C N 

166 Surgery Implantable Staple, Clamp, 

Clip for Suturing Apparatus 

878.4750 II GDW 3 C N 

167 Surgery Percutaneous biopsy device 878.4800 I MJG 3 C Y 

168 Surgery Gastro-Urology needle 878.4800 I FHR 3 C Y 

169 Surgery Aspiration and injection 

needle 

878.4800 I GAA 3 C Y 

170 Surgery Biopsy Brush 878.4800 I GEE 1 C Y 

171 Surgery Blood Lancet 878.4800 I FMK 1 C Y 

172 Surgery Bone Hook 878.4800 I KIK 1 C Y 

173 Surgery Cardiovascular Biopsy 

Needle 

878.4800 I DWO 3 C Y 

174 Surgery Clamp 878.4800 I GDJ 1 C Y 

175 Surgery Clamp 878.4800 I HXD 1 C Y 

176 Surgery Curette 878.4800 I HTF 1 C Y 

177 Surgery Disposable Surgical Instrument 878.4800 I KDC 1 C Y 

178 Surgery Disposable Vein Stripper 878.4800 I GAJ 1 C Y 

179 Surgery Dissector 878.4800 I GDI 1 C Y 

180 Surgery Forceps 878.4800 I GEN 2 C Y 

181 Surgery Forceps 878.4800 I HTD 2 C Y 

182 Surgery Gouge 878.4800 I GDH 1 C Y 

183 Surgery Hemostatic Clip Applier 878.4800 I HBT 2 C Y 

184 Surgery Hook 878.4800 I GDG 1 C Y 

185 Surgery Manual Instrument 878.4800 I MDM, 

MDW 

1 C Y 

186 Surgery Manual Retractor 878.4800 I GZW 1 C Y 

187 Surgery Manual Saw and Accessories 878.4800 I GDR HAC 1 C Y 

188 Surgery Manual Saw and Accessories 878.4800 I HAC 1 C Y 

189 Surgery Manual Surgical Chisel 878.4800 I FZO 1 C Y 

190 Surgery Mastoid Chisel 878.4800 I JYD 1 C Y 

191 Surgery Orthopedic Cutting Instrument 878.4800 I HTZ 1 C Y 

192 Surgery Orthopedic Spatula 878.4800 I HXR 1 C Y 

56924 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

193 Surgery Osteotome 878.4800 I HWM 1 C Y 

194 Surgery Rasp 878.4800 I GAC 1 C Y 

195 Surgery Rasp 878.4800 I HTR 1 C Y 

196 Surgery Retractor 878.4800 I GAD 1 C Y 

197 Surgery Retractor 878.4800 I HXM 1 C Y 

198 Surgery Saw 878.4800 I HSO 1 C Y 

199 Surgery Scalpel Blade 878.4800 I GES 1 C Y 

200 Surgery Scalpel Handle 878.4800 I GDZ 1 C Y 

201 Surgery Scissors 878.4800 I LRW 1 C Y 

202 Surgery Snare 878.4800 I GAE 1 C Y 

203 Surgery Spatula 878.4800 I GAF 1 C Y 

204 Surgery Staple Applier 878.4800 I GEF 2 C Y 

205 Surgery Stapler 878.4800 I GAG 2 C Y 

206 Surgery Stomach and Intestinal 

Suturing Apparatus 

878.4800 I FHM 2 C Y 

207 Surgery Surgical Curette 878.4800 I FZS 1 C Y 

208 Surgery Surgical Cutter 878.4800 I FZT 1 C Y 

209 Surgery Surgical Knife 878.4800 I EMF 1 S Y 

210 Surgery Laser Powered Instrument 878.4810 II GEX 2 C N 

211 Surgery AC-Powered Motor 878.4820 I GEY 2 C Y 

212 Surgery Bit 878.4820 I GFG 1 C Y 

213 Surgery Bur 878.4820 I GFF, GEY 1 C Y 

214 Surgery Cardiovascular Surgical 

Saw Blade 

878.4820 I DWH 1 C Y 

215 Surgery Chisel (Osteotome) 878.4820 I KDG 1 C Y 

216 Surgery Dermatome 878.4820 I GFD 1 C Y 

217 Surgery Electrically Powered Saw 878.4820 I DWI 2 C Y 

218 Surgery Pneumatic Powered Motor 878.4820 I GET 2 C Y 

219 Surgery Pneumatically Powered 

Saw 

878.4820 I KFK 2 C Y 

220 Surgery Powered Saw and Accessories 878.4820 I HAB 2 C Y 

221 Surgery Saw Blade 878.4820 I GFA 1 C Y 

222 Surgery Nonpneumatic Tourniquet 878.5900 I GAX 1 N Y 

223 Surgery Pneumatic Tourniquet 878.5910 I KCY 1 N Y 

224 Surgery Endoscopic Staplers 888.4540 I HXJ 2 C Y 

225 Surgery Trocar 876.1500 

870.1390 

II GCJ, DRC 3 C N 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56925 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

226 Surgery Surgical Cutting Accessories 878.4800, 

874.4420 

I GDZ, GDX, 

GES, 

KBQ, 

KAS 

2 C Y 

227 Surgery Electrosurgical Electrodes/ 

Handles/Pencils 

876.4300 

878.4400 

II HAM, GEI, 

FAS 

2 C N 

228 Surgery Scissor Tips 878.4800, 

884.4520, 

874.4420 

I LRW, HDK, 

HDJ, 

JZB, 

KBD 

2 C Y 

229 Surgery Laser Fiber Delivery Systems 878.4810 

874.4500 

886.4390 

884.4550 

886.4690 

II GEX EWG 

LLW 

HQF 

HHR 

HQB 

1 C N 

ARisk categorization may be either: 

1 = low risk according to RPS 

2 = moderate risk according to RPS 

3 = high risk according to RPS 

3* = high risk due to neurological use 

See section II of this document, ‘‘FDA’s Implementation of New Section 510(o) of the Act’’ for methodology and criteria used to identify the 

risk. 

Dated: September 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19510 Filed 9–28–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to OMB under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer at (301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Maternal and Child 

Health Services Title V Block Grant 

Program—Guidance and Forms for the 

Title V Application/Annual Report, 

OMB No.0915–0172: Revision 

The Health Resources and Services 

Administration (HRSA) proposes to 

revise the Maternal and Child Health 

Services Title V Block Grant Program—

Guidance and Forms for the 

Application/Annual Report. The 

guidance is used annually by the 50 

States and 9 jurisdictions in making 

application for Block Grants under Title 

V of the Social Security Act, and in 

preparing the required annual report. 

The proposed revisions follow and 

build on extensive consultation received 

from a workgroup convened to provide 

suggestions to improve the guidance 

and forms. The proposed revisions are 

editorial and technical revisions based 

on the experience of the states and 

jurisdictions in using the guidance and 

forms since 2003. 

Two new performance measures were 

developed (obesity in children aged 2 to 

5 years; and smoking in the last 

trimester of pregnancy) and two existing 

performance measures were either 

removed entirely (low birth weight) or 

incorporated into an existing health 

status capacity indicator (eligible 

children receiving services under 

Medicaid). This will result in no net 

increase in the number of performance 

measures. In addition, the directions in 

the guidance for the Health Systems 

Capacity Indicators (HSCI) were 

expanded to enhance clarification. This 

proposed change will make it easier for 

the states to report on these indicators. 

The existing electronic system used 

by the states to submit their Block Grant 

Application and Annual Report has also 

been enhanced. First, using the 

electronic system, the narrative from the 

prior year’s submission is available 

online in the system so that the 

applicant need only edit those sections 

that have changed. This reduces burden 

by avoiding duplicating material. For 

national performance measures 2–6, the 

data obtained from the National Survey 

of Children with Special Health Care 

Needs are pre-populated which 

eliminates the need to retrieve and enter 

data from this survey, unless the states 

choose to use another data source. Also, 

notes from the prior year’s submission 

are available to the states allowing for 

more efficient updating through edits 

rather then recreating them. Data are 

entered once (in a data entry field on a 

given form), and where those data are 

referenced elsewhere, the value is