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Notice

Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data

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Information about this document as published in the Federal Register.

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a list (List I) of critical reprocessed single-use devices (SUDs) whose exemption from premarket submission is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is necessary in a premarket notification (510(k)); and a list (List II) of reprocessed SUDs that are currently subject to 510(k) requirements for which FDA has determined that validation data, as specified under MDUFMA, is necessary in a 510(k). FDA is requiring submission of these data to ensure that these reprocessed SUDs are substantially equivalent to predicate devices in accordance with MDUFMA.

DATES:

These actions are effective April 30, 2003. Manufacturers of SUDs identified in List I whose exemption is being terminated must submit 510(k)s for these devices by July 30, 2004, or their devices may no longer be marketed. Manufacturers who already have clearance letters for SUDs identified in List II must submit validation data for these devices by January 30, 2004, or marketing of these devices must cease.

ADDRESSES:

Submit written comments to the Dockets Management Branch (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 on Lists I and II should be identified with the docket number found in brackets in the heading of this document.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

On October 26, 2002, MDUFMA (Pub. L. 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 will no longer be exempt from premarket notification requirements. Manufacturers of these identified devices will need to submit 510(k)s that include validation data to be specified by FDA. Reprocessors of certain SUDs that are currently subject to cleared 510(k)s also will need to submit the validation data specified by the agency.

In the near future, FDA will publish a guidance document providing more specific information about the types of validation data that should be submitted in premarket notification submissions for the reprocessed SUDs listed in this notice.

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.”

B. Reprocessed SUDs Exempt From Premarket Notification

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 Start Printed Page 23140the 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.

1. Requirements for Critical Reprocessed SUDs

MDUFMA requires FDA to review the critical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require premarket notification to ensure their substantial equivalence to predicate devices. By April 26, 2003, FDA must identify in a Federal Register notice those critical reprocessed SUDs whose exemption from premarket notification will be terminated. List I in this Federal Register notice implements this MDUFMA requirement.

In accordance with MDUFMA, manufacturers of the devices identified in List I must submit 510(k)s that include 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 this notice or no longer market their device.

2. Requirements for Semicritical Reprocessed SUDs

MDUFMA also requires FDA to review the semicritical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require premarket notification to ensure their substantial equivalence to predicate devices. FDA must identify these devices in a notice published in the Federal Register by April 26, 2004. Manufacturers of devices identified at that time will be required to submit 510(k)s that include 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 that notice or no longer market their device.

3. Requirements for Noncritical Reprocessed SUDs

MDUFMA does not require FDA to take any action under this section for noncritical SUDs that are exempt from premarket submission requirements.

C. Reprocessed SUDs Already Subject to Premarket Notification Requirements

MDUFMA also requires FDA to review the types of reprocessed SUDs already subject to premarket notification requirements and to identify which of these devices require the submission of validation data to ensure their substantial equivalence to predicate devices. FDA must publish a list of these devices in the Federal Register by April 26, 2003, and update the list as necessary. List II of this Federal Register notice implements this MDUFMA requirement. The devices on List II may be critical, semicritical, or noncritical reprocessed SUDs.

1. For devices identified in List II that have not yet been cleared through the 510(k) process, manufacturers must submit 510(k)s that include validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in § 807.87, upon publication of this notice in order to market these devices. FDA will soon publish guidance to help submitters understand what types of validation data should be included in these 510(k)s.

2. For devices identified in List II that already have been cleared through the 510(k) process, manufacturers must submit validation data regarding cleaning, sterilization, and functional performance within nine months of publication of this notice or marketing must cease. FDA will soon publish guidance to explain how a 510(k) holder may submit the additional data now being required to support an earlier clearance.

II. FDA's Implementation of New Section 510(o) of the Act

FDA used a number of criteria to determine which device types should be included in the lists required by MDUFMA. As part of its consideration, FDA relied upon the Review Prioritization Scheme (RPS) it described in the February 2000 draft guidance document entitled “Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme.” [2] In the RPS guidance, FDA set forth factors that could be used to evaluate risk associated with reprocessed SUDs. This approach assigned an overall risk to each SUD based on: (1) The risk of infection and (2) the risk of inadequate performance following reprocessing. Based on these risk factors, three categories of risk (high, moderate, and low) were developed. The designation of “high risk” was assigned to those devices that posed the greatest risk of infection and inadequate performance after reprocessing. In response to several comments about potential subjectivity of the RPS, FDA did not use the RPS approach when the agency finalized its enforcement priorities for reprocessed SUDs on August 14, 2000.

FDA has determined, however, that the RPS is an appropriate risk-based tool for developing the lists required by MDUFMA because the RPS identifies the devices that are likely to raise the most concerns about both infection transmission and inadequate performance following reprocessing. In formulating these lists, the agency also had the benefit of comments from stakeholders and an internal centerwide committee to evaluate the results of the RPS and ensure its consistency. In addition, there was a final review of all the devices on these lists by the Director of the Office of Device Evaluation. In this context, the agency believes these steps have adequately addressed concerns about the subjectivity of the RPS.

In addition to the previous criterion, FDA used one other criterion to identify those reprocessed SUDs that will be subject to the new requirements established by MDUFMA. The agency has included in these lists all reprocessed SUDs intended to come in contact with tissue at high risk of being infected with the causative agents of Creutzfeldt-Jakob Disease (CJD). These are generally devices intended for use in neurosurgery ophthalmology. This criterion was included in FDA's evaluation because insufficient scientific information exists at this time to establish standard methods to eliminate CJD infectious agents.

Therefore, in order to develop the two lists required by MDUFMA, FDA used the following process. First, the agency identified the types of SUDs that are being reprocessed. FDA did this by searching the 510(k) database for any 510(k)s that had been submitted for reprocessed SUDs and by asking original equipment manufacturers and reprocessors to provide information about types of devices that were being reprocessed. Second, FDA determined whether these devices are “critical,” “semi-critical,” or “non-critical”. (These Start Printed Page 23141definitions reflect the Spaulding [3] classification and are the same definitions FDA used earlier in developing its RPS.) FDA then applied the criteria described previously and “listed” any reprocessed SUD that was either “high” risk according to the RPS or intended to come in contact with tissue at high risk of being infected with the causative agents of CJD.

All devices identified in List I (previously exempt from 510(k)) have been determined to be critical reprocessed SUDs. In addition to being critical, they are either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with CJD. It should be noted that not all exempt devices that are critical have been listed. Critical reprocessed SUDs that are not listed in List I at this time may be reconsidered in subsequent updates of the list. The devices in List II (devices currently subject to 510(k) requirements that now will require the submission of validation data) are either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with the causative agents of CJD.

FDA has also provided a reference list in Attachment 1. To show how FDA evaluated the risk of a specific device, Attachment 1 includes the entire group of devices FDA considered when identifying the reprocessed SUDs in Lists I and II, and shows how FDA applied the criteria that determined whether the device would be identified on either of these lists.

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. The agency received several comments that identified specific reprocessed SUDs to be included in Lists I and II. The agency considered these recommendations while finalizing this document. Although FDA's lists do not include all the reprocessed SUDs that were recommended, the agency believes that those devices that pose the greatest risk of infection transmission and inadequate performance have been identified. The agency recognizes, however, that these lists may need to be re-evaluated and updated over time. Therefore, FDA will consider comments from the public on additional devices that should be included in the lists at any time. The agency also notes that MDUFMA permits FDA to request validation data for a device type that is subject to 510(k) clearance but not yet included in List II. If this were to occur, FDA would ensure that manufacturers were aware of this change in the 510(k) submission requirements for that type of device by promptly updating the list.

Finally, FDA received one comment that suggested the agency's prior determinations about risk associated with reprocessed SUDs precluded FDA from now requiring 510(k)s for devices that were previously exempt or additional data for devices that were already cleared. FDA believes that this comment ignores the existence of MDUFMA's requirements. It is true that FDA had initially developed a regulatory approach for reprocessed SUDs that sought to treat those devices and original devices in a similar manner and that FDA had not required additional data to be submitted for certain reprocessed SUDs under that approach. However, through MDUFMA Congress clearly stated its intent to have the agency re-examine its policy with respect to reprocessed SUDs and legislated additional controls for those devices. FDA is committed to fulfilling its responsibilities under MDUFMA. The development and publication of these lists is part of the agency's implementation of these new statutory provisions.

List I.—Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data

[To be submitted by July 26, 2004]

21 CFR sectionClassification nameProduct code for Non-reprocessed deviceProduct code for reprocessed deviceProduct code name for reprocessed device
872.3240Dental burDiamond CoatedNMEDental diamond coated bur.
872.4535Dental diamond instrumentDZPNLDDental diamond instrument.
872.4730Dental injection needleDZMNMWDental needle.
874.4140Ear, nose, and throat burMicrodebriderNLYENT high speed microdebrider.
874.4140Ear, nose, and throat burDiamond CoatedNLZENT diamond coated bur.
874.4420Ear, nose, throat manual surgical * * *KAB, KBG, KCINLBLaryngeal, Sinus, Tracheal trocar.
878.4200Introduction/drainage catheter and accessoriesGCBNMTCatheter needle.
878.4800Manual surgical instrumentMJGNNAPercutaneous biopsy device.
878.4800Manual surgical instrumentFHRNMUGastro-Urology needle.
878.4800Manual surgical instrument for * * *DWONLKCardiovascular biopsy needle.
878.4800Manual surgical instrument for * * *GAANNCAspiration and injection.
882.4190Forming/cutting clip instrumentHBSNMNForming/cutting clip instrument.
884.1730Laparoscopic insufflator * * *HIFNMILaparoscopic insufflator and accessories.
884.4530OB/GYN specialized manual instrumentHFBNMGGynecological biopsy forceps.
886.4350Manual ophthalmic surgical instrumentHNNNLAOphthalmic knife.
Start Printed Page 23142

List II.—Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Will Now Require The Submission of Validation Data 1

[Manufacturers who already have 510(k) clearance for these devices must submit validation data by January 26, 2004. Any new 510(k) will require validation data upon publication of this list.]

21 CFR sectionClassification nameProduct code for non-reprocessed deviceProduct code for reprocessed deviceProduct code name for reprocessed device
UnclassifiedOocyte aspiration needlesMHKNMOOocyte aspiration needles.
UnclassifiedPercutaneous transluminal angioplasty catheter angioplasty catheterLITNMMTransluminal peripheral angioplasty catheter.
UnclassifiedUltrasonic surgical instrumentLFLNLQUltrasonic scalpel.
868.5150Anesthesia conduction needleBSPNNHAnesthetic conduction needle (with or without introducer).
868.5150Anesthesia conduction needleMIANMRShort term spinal needle.
868.5730Tracheal tubeBTRNMATracheal tube (with or without connector).
868.5905Non­con­tin­u­ous (IPPB)BZDNMCNoncontinuous ventilator (respirator) mask.
870.1200Diagnostic intravascular catheterDQONLIAngiography catheter.
870.1220Electrode recording catheterDRFNLHElectrode recording catheter.
870.1220Electrode recording catheterMTDNLGIntracardiac mapping catheter.
870.1230Fiberoptic oximeter catheterDQENMBFiberoptic oximeter catheter.
870.1280Steerable catheterDRANKSSteerable catheter.
870.1290Steerable catheter control systemDXXNKRSteerable catheter control system.
870.1330Catheter guide wireDQXNKQCatheter guide wire.
870.1390TrocarDRCNMKCardiovascular trocar.
870.1650Angiographic injector and syringeDXTNKTAngiographic injector and syringe.
870.1670Syringe actuator for injectorDQFNKWInjector for actuator syringe.
870.2700OximeterMUDNMDTissue saturation oximeter.
870.2700OximeterDQANLFOximeter.
870.3535Intra-aortic balloon and control systemDSPNKOIntra-aortic balloon and control system.
870.4450Vascular clampDXCNMFVascular clamp.
870.4885External vein stripperDWQNLJExternal vein stripper.
872.5470Orthodontic plastic bracketDYWNLCOrthodontic plastic bracket.
874.4680Bronchoscope (flexible or rigid) and accessoriesBWHNLEBronchoscope (nonrigid) biopsy forceps.
876.1075Gastro-Urology biopsy instrumentFCGNMXG-U biopsy needle and needle set.
876.1075Gastroenterology-urology biopsy instrumentKNWNLSBiopsy instrument.
876.1500Endoscope and accessoriesFBK, FHPNMYEndoscopic needle.
876.1500Endoscope and accessoriesMPANKZEndoilluminator.
876.1500Endoscope and accessoriesGCJNLMGeneral and plastic surgery laparoscope.
876.1500Endoscope and accessoriesFHONLXSpring-loaded Pneumoperitoneum Needle.
876.4300Endoscopic electrosurgical unit and accessoriesFASNLWActive urological electrosurgical electrode.
876.4300Endoscopic unit accessoriesFEHNLVFlexible suction coagulator electrode.
876.4300Endoscopic electrosurgical unit and accessoriesKGENLUElectric biopsy forceps.
876.4300Endoscopic electrosurgical unit and accessoriesFDINLTFlexible snare.
876.4300Endoscopic electrosurgical unit and accessoriesKNSNLREndoscopic (with or without accessories) Electrosurgical unit.
876.5010Biliary catheter and accessoriesFGENMLBiliary catheter.
876.5540Blood access device and accessoriesLBWNNFSingle needle dialysis set (co-axial flow).
876.5540Blood access device and accessoriesFIENNEFistula needle.
876.5820Hemodialysis systems and accessoriesFIFNNGSingle needle dialysis set with and accessories uni-directional pump.
878.4300Implantable clipFZPNMJImplantable clip.
878.4750Implantable stapleGDWNLLImplantable staple.
880.5570Hypodermic single lumen needleFMINKKHypodermic single lumen needle.
880.5860Piston syringeFMFNKNPiston syringe.
882.4300Manual cranial drills, burrs, trephines and accessoriesHBGNLO(Manual) drills, burrs, burrs, trephines and accessories.
882.4305Powered compound cranial drills, burrs, trephines . . .HBFNLP(Powered, compound) drills, burrs, trephines and accessories.
882.4310Powered simple cranial drills, burrs, trephinesHBENLN(Simple, powered) drills, burrs, trephines and accessories.
884.1720Gynecologic laparoscope and accessoriesHETNMHGynecologic laparoscope (and accessories).
884.6100Assisted reproduction needleMQENNBAssisted reproduction needle.
886.4370KeratomeHMY, HNONKYKeratome blade.
886.4670Phacofragmentation systemHQCNKXPhacoemulsification needle.
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892.5730Radionuclide brachytherapy sourceIWFNMPIsotope needle.
1 Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in “Guidance for Hemodialyzer Reuse Labeling” (final draft issued on October 6, 1995).

III. Comments

You may submit written or electronic comments on these lists to the Dockets Management Branch (see ADDRESSES). You may submit a single copy of an electronic comment to http://www.fda.gov/​dockets/​ecomments. You should submit two copies of any mailed comments but individuals may submit one copy. You should identify your comment 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 specialtyDevice typeRegulation No.ClassProduct codeRisk 1,2,3,3*Critical/semi-critical/non-criticalPremarket exempt
1CardioCardiopulmonary Bypass MarkerUnclassifiedMAB1CN
2CardioPercutaneous & Operative Transluminal Coronary Angioplasty Catheter (PCTA)post amendmentIIILOX3CN
3CardioPercutaneous Ablation ElectrodePost amendmentIIILPB3CN
4CardioPeripheral Transluminal Angioplasty (PTA) CatheterUnclassifiedLIT3CN
5CardioBlood-Pressure Cuff870.1120IIDXQ1NN
6CardioAngiography Catheter870.1200IIDQO3CN
7CardioElectrode Recording Catheter870.1220IIDRF3CN
8CardioHigh-Density Array Catheter870.1220IIMTD3CN
9CardioFiberoptic Oximeter Catheter870.1230IIDQE3CN
10CardioSteerable Catheter870.1280IIDRA3CN
11CardioSteerable Catheter Control System870.1290IIDXX3CN
12CardioGuide Wire870.1330IIDQX3CN
13CardioAngiographic Needle870.1390IIDRC3CN
14CardioTrocar870.1390IIDRC3CN
15CardioSyringes870.1650IIDXT3CN
16CardioInjector Type Syringe Actuator870.1670IIDQF3CN
17CardioOximeter870.2700IIDQA3NN
18CardioTissue Saturation Oximeter870.2700IIMUD3CN
19CardioIntra-Aortic Balloon System870.3535IIIDSP3CN
20CardioVascular Clamp870.4450IIDXC3CN
21CardioDevice, Stabilizer, Heart870.4500IMWS2CY
22CardioExternal Vein Stripper870.4885IIDWQ3CN
23CardioCompressible Limb Sleeve870.5800IIJOW1NN
24DentalBur872.3240IEJL1CY
25DentalDiamond Coated Bur872.3240IEJL3CY
26DentalDiamond Instrument872.4535IDZP3CY
27DentalAC-Powered Bone Saw872.4120IIDZH2CN
28DentalManual Bone Drill and Wire Driver872.4120IIDZJ2CN
29DentalPowered Bone Drill872.4120IIDZI2CN
30DentalIntraoral Drill872.4130IDZA1CY
31DentalInjection Needle872.4730IDZM3CY
32DentalMetal Orthodontic Bracket872.5410IEJF3SY
33DentalPlastic Orthodontic Bracket872.5470IIDYW3SN
34ENTBur874.4140IEQJ1CY
35ENTDiamond Coated Bur874.4140IEQJ3CY
36ENTMicrodebrider874.4140IEQJ3CY
37ENTMicrosurgical Argon Fiber Optic Laser Cable, For Uses Other Than Otology, Including Laryngology & General Use In Otolarngology874.4490IILMS1SN
38ENTMicrosurgical Argon Fiber Optic Laser Cable, For Use In Otology874.4490IILXR1SN
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39ENTMicrosurgical Carbon-Dioxide Fiber Optic Laser Cable874.4500IIEWG1SN
40ENTBronchoscope Biopsy Forceps (Non-Rigid)874.4680IIBWH3SN
41ENTBronchoscope Biopsy Forceps (Rigid)874.4680IIJEK1SN
42Gastro/UrologyBiopsy Forceps Cover876.1075IFFF1SY
43Gastro/UrologyBiopsy Instrument876.1075IIKNW3SN
44Gastro/UrologyBiopsy Needle Set876.1075IIFCG3SN
45Gastro/UrologyBiopsy Punch876.1075IIFCI2SN
46Gastro/UrologyMechanical Biopsy Instrument876.1075IIFCF2SN
47Gastro/UrologyNon-Electric Biopsy Forceps876.1075IFCL3SY
48Gastro/UrologyCytology Brush For Endoscope876.1500IIFDX2SN
49Gastro/UrologyEndoscope Accessories876.1500IIKOG2SN
50Gastro/UrologyExtraction Balloons/Baskets876.1500IIKOG2SN
51Gastro/UrologyEndoscopic Needle876.1500IIFBK3CN
52Gastro/UrologySimple Pneumoperitoneum Needle876.1500IIFHP3CN
53Gastro/UrologySpring Loaded Pneumoperitoneum Needle876.1500IIFHO3CN
54Gastro/UrologyActive Electrosurgical Electrode876.4300IIFAS3SN
55Gastro/UrologyBiliary Sphincterotomes876.5010, 876.1500IIFGE3SN
56Gastro/UrologyElectric Biopsy Forceps876.4300IIKGE3SN
57Gastro/UrologyElectrosurgical Endoscopic Unit (With Or Without Accessories)876.4300IIKNS3SN
58Gastro/UrologyFlexible Snare876.4300IIFDI3SN
59Gastro/UrologyFlexible Suction Coagulator Electrode876.4300IIFEH3SN
60Gastro/UrologyFlexible Stone Dislodger876.4680IIFGO3SY
61Gastro/UrologyMetal Stone Dislodger876.4680IIFFL3SY
62Gastro/UrologyNeedle Holder876.4730IFHQ1CY
63Gastro/UrologyNon-Electrical Snare876.4730IFGX1SY
64Gastro/UrologyUrological Catheter876.5130IIKOD2SN
65Gastro/UrologySingle Needle Dialysis Set876.5540IILBW, FIE3CN
66Gastro/UrologyHemodialysis Blood Circuit Accessories876.5820IIKOC2SN
67Gastro/UrologySingle Needle Dialysis Set876.5820IIFIF3CN
68GE/UHemorrhoidal Ligator876.4400IIFHN2CN
69General HospitalImplanted, Programmable Infusion PumpPost-amendmentIIILKK3CN
70General HospitalNeedle Destruction DevicePost-amendmentIIIMTV1NN
71General HospitalNon-Powered Flotation Therapy Mattress880.5150IIKY2NY
72General HospitalNon AC-Powered Patient Lift880.5510IFSA2NY
73General HospitalAlternating Pressure Air Flotation Mattress880.5550IIFNM1NY
Start Printed Page 23145
74General HospitalTemperature Regulated Water Mattress880.5560IFOH2NY
75General HospitalHypodermic Single Lumen Needle880.5570IIFMI3CN
76General HospitalPiston Syringe880.5860IIFMF3CN
77General HospitalMattress Cover (Medical Purposes)880.6190IFMW2NY
78General HospitalDisposable Medical Scissors880.6820IJOK1NY
79General HospitalIrrigating Syringe880.6960IKYZ, KYY1CY
80Infection ControlSurgical Gowns878.4040IIFYA1CN
81LabBlood Lancet878.4800IFMK1CY
82NeuroClip Forming/Cutting Instrument,882.4190IHBS3*CY
83NeuroDrills, Burrs, Trephines & Accessories (Manual)882.4300IIHBG3*CN
84NeuroDrills, Burrs, Trephines & Accessories (Compound, Powered)882.4305IIHBF3*CN
85NeuroDrills, Burrs, Trephines & Accessories (Simple, Powered)882.4310IIHBE3*CN
86OB/GYNOocyte aspiration needleUnclassifiedIIMHK3CN
87OB/GYNLaparoscope Accessories884.1720IHET2CY
88OB/GYNLaparoscope Accessories884.1720IIHET3CN
89OB/GYNLaparoscopic Dissectors884.1720IHET2CY
90OB/GYNLaparoscopic Graspers884.1720IHET2CY
91OB/GYNLaparoscopic Scissors884.1720IHET2CY
92OB/GYNInsufflator Accessories (tubing, Verres needle, kits)884.1730IIHIF3CY
93OB/GYNLaparoscopic Insufflator884.1730IIHIF2NN
94OB/GYNEndoscopic Electrocautery And Accessories884.4100IIHIM2NN
95OB/GYNGynecologic Electrocautery (And Accessories)884.4120IIHGI2NN
96OB/GYNEndoscopic Bipolar Coagulator-Cutter (And Accessories)884.4150IIHIN2NN
97OB/GYNCuldoscopic Coagulator (And Accessories)884.4160IIHFI2NN
98OB/GYNEndoscopic Unipolar Coagulator-Cutter (And Accessories)884.4160IIKNF2NN
99OB/GYNHysteroscopic Coagulator (And Accessories)884.4160IIHFH2NN
100OB/GYNUnipolar Laparoscopic Coagulator (And Accessories)884.4160IIHFG2NN
101OB/GYNEpisiotomy Scissors884.4520IHDK1CY
102OB/GYNUmbilical Scissors884.4520IHDJ1CY
103OB/GYNBiopsy Forceps884.4530IHFB3CY
104OB/GYNAssisted reproduction needle884.6100IIMQE3CN
105OphthalmicEndoilluminator876.1500IIMPA3*CN
106OphthalmicSurgical Drapes878.4370IIKKX2CN
107OphthalmicOphthalmic Knife886.4350IHNN3CY
108OphthalmicKeratome Blade886.4370Inot exemptHMY, HNO3CN
109OphthalmicPhacoemulsification Needle886.4670IIHQC3CN
110OphthalmicPhacoemulsification/Phacofragmentation Fluidic886.4670IIMUS2CN
111OphthalmicPhacofragmentation Unit886.4670IIHQC1NN
112OrthoSaw Blades878.4820IGFA, DWH, GEY, GET1CY
113OrthoSurgical Drills878.4820IGEY, GET1CY
114OrthoArthroscope accessories888.1100IIHRX2CY
115OrthoBone Tap888.4540IHWX1CY
116OrthoBurr888.4540IHTT1CY
117OrthoCarpal Tunnel Blade888.4540ILXH2CY
118OrthoCountersink888.4540IHWW1CY
119OrthoDrill Bit888.4540IHTW1CY
Start Printed Page 23146
120OrthoKnife888.4540IHTS1CY
121OrthoManual Surgical Instrument888.4540ILXH1CY
122OrthoNeedle Holder888.4540IHXK1CY
123OrthoReamer888.4540IHTO1CY
124OrthoRongeur888.4540IHTX1CY
125OrthoScissors888.4540IHRR1CY
126OrthoStaple Driver888.4540IHXJ1CY
127OrthoTrephine888.4540IHWK1CY
128OrthoFlexible Reamers/Drills886.4070 878.4820IGEY, HRG1CY
129OrthoExternal Fixation Frame888.3040 888.3030IIJEC KTW KTT2NN
130Physical MedicineNon-Heating Lamp for Adjunctive Use Inpatient TherapyUnclassifiedNHN1NN
131Physical MedicineElectrode Cable,890.1175IIIKD1NY
132Physical MedicineExternal Limb Component, Hip Joint890.3420IISL2NY
133Physical MedicineExternal Limb Component, Knee Joint890.3420IISY2NY
134Physical MedicineExternal Limb Component, Mechanical Wrist890.3420IISZ2NY
135Physical MedicineExternal Limb Component, Shoulder Joint890.3420IIQQ2NY
136Plastic SurgeryStapler878.4800IGAG, GEF, FHM, HBT2CY
137RadiologyIsotope Needle892.5730IIIWF3CN
138RespEndotracheal Tube ChangerUnclassifiedIIILNZ3CN
139RespAnesthesia conduction needle868.5150IIBSP3CN
140RespShort term spinal needle868.5150IIMIA3CN
141RespRespiratory Therapy And Anesthesia Breathing Circuits868.5240ICAI2SY
142RespOral And Nasal Catheters868.5350IBZB1CY
143RespGas Masks868.5550IBSJ1SY
144RespBreathing Mouthpiece868.5620IBYP1NY
145RespTracheal Tube868.5730IIBTR3CN
146RespAirway Connector868.5810IBZA2SY
147RespCPAP Mask868.5905IIBZD3SN
148RespEmergency Manual Resuscitator868.5915IIBTM2SN
149RespTracheobronchial Suction Catheter868.6810IBSY3SY
150SurgeryAC-powered Orthopedic Instrument and accessoriesUnclassifiedHWE2CN
151SurgeryBreast Implant Mammary SizerUnclassifiedMRD1CN
152SurgeryUltrasonic Surgical InstrumentUnclassifiedLFL3CN
153SurgeryTrocar874.4420IKAB, KBG, KCI3CY
154SurgeryEndoscopic Blades876.1500IIGCP, GCR2CN
155SurgeryEndoscopic Guidewires876.1500IIGCP, GCR1CN
156SurgeryInflatable External Extremity Splint878.3900IFZF1NY
157SurgeryNoninflatable External Extremity Splint878.3910IFYH1NY
158SurgeryCatheter needle878.4200IGCB3CY
159SurgeryImplantable Clip878.4300IIFZP3CN
160SurgeryElectrosurgical And Coagulation Unit With Accessories878.4400IIBWA2CN
161SurgeryElectrosurgical Apparatus878.4400IIHAM2CN
162SurgeryElectrosurgical Cutting & Coagulation Device & Accessories878.4400IIGEI2CN
163SurgeryElectrosurgical Device878.4400IIDWG2CN
164SurgeryElectrosurgical Electrode878.4400IIJOS2CN
165SurgeryImplantable Staple, Clamp, Clip for Suturing Apparatus878.4750IIGDW3CN
166SurgeryPercutaneous biopsy device878.4800IMJG3CY
167SurgeryGastro-Urology needle878.4800IFHR3CY
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168SurgeryAspiration and injection needle878.4800IGAA3CY
169SurgeryBiopsy Brush878.4800IGEE1CY
170SurgeryBlood Lancet878.4800IFMK1CY
171SurgeryBone Hook878.4800IKIK1CY
172SurgeryCardiovascular Biopsy Needle878.4800IDWO3CY
173SurgeryClamp878.4800IGDJ1CY
174SurgeryClamp878.4800IHXD1CY
175SurgeryCurette878.4800IHTF1CY
176SurgeryDisposable Surgical Instrument878.4800IKDC1CY
177SurgeryDisposable Vein Stripper878.4800IGAJ1CY
178SurgeryDissector878.4800IGDI1CY
179SurgeryForceps878.4800IGEN2CY
180SurgeryForceps878.4800IHTD2CY
181SurgeryGouge878.4800IGDH1CY
182SurgeryHemostatic Clip Applier878.4800IHBT2CY
183SurgeryHook878.4800IGDG1CY
184SurgeryManual Instrument878.4800IMDM, MDW1CY
185SurgeryManual Retractor878.4800IGZW1CY
186SurgeryManual Saw And Accessories878.4800IGDR HAC1CY
187SurgeryManual Saw And Accessories878.4800IHAC1CY
188SurgeryManual Surgical Chisel878.4800IFZO1CY
189SurgeryMastoid Chisel878.4800IJYD1CY
190SurgeryOrthopedic Cutting Instrument878.4800IHTZ1CY
191SurgeryOrthopedic Spatula878.4800IHXR1CY
192SurgeryOsteotome878.4800IHWM1CY
193SurgeryRasp878.4800IGAC1CY
194SurgeryRasp878.4800IHTR1CY
195SurgeryRetractor878.4800IGAD1CY
196SurgeryRetractor878.4800IHXM1CY
197SurgerySaw878.4800IHSO1CY
198SurgeryScalpel Blade878.4800IGES1CY
199SurgeryScalpel Handle878.4800IGDZ1CY
200SurgeryScissors878.4800ILRW1CY
201SurgerySnare878.4800IGAE1CY
202SurgerySpatula878.4800IGAF1CY
203SurgeryStaple Applier878.4800IGEF2CY
204SurgeryStapler878.4800IGAG2CY
205SurgeryStomach And Intestinal Suturing Apparatus878.4800IFHM2CY
206SurgerySurgical Curette878.4800IFZS1CY
207SurgerySurgical Cutter878.4800IFZT1CY
208SurgerySurgical Knife878.4800IEMF1SY
209SurgeryLaser Powered Instrument878.4810IIGEX2CN
210SurgeryAc-Powered Motor878.4820IGEY2CY
211SurgeryBit878.4820IGFG1CY
212SurgeryBur878.4820IGFF, GEY1CY
213SurgeryCardiovascular Surgical Saw Blade878.4820IDWH1CY
214SurgeryChisel (Osteotome)878.4820IKDG1CY
215SurgeryDermatome878.4820IGFD1CY
216SurgeryElectrically Powered Saw878.4820IDWI2CY
217SurgeryPneumatic Powered Motor878.4820IGET2CY
218SurgeryPneumatically Powered Saw878.4820IKFK2CY
219SurgeryPowered Saw And Accessories878.4820IHAB2CY
220SurgerySaw Blade878.4820IGFA1CY
221SurgeryNonpneumatic Tourniquet878.5900IGAX1NY
222SurgeryPneumatic Tourniquet878.5910IKCY1NY
223SurgeryEnodoscopic Staplers888.4540IHXJ2CY
224SurgeryTrocar876.1500 870.1390IIGCJ, DRC3CN
225SurgerySurgical Cutting Accessories878.4800, 874.4420IGDZ, GDX, GES, KBQ, KAS2CY
226SurgeryElectrosurgical Electrodes/Handles/Pencils876.4300 878.4400IIHAM, GEI, FAS2CN
Start Printed Page 23148
227SurgeryScissor Tips878.4800, 884.4520, 874.4420ILRW, HDK, HDJ, JZB, KBD2CY
228SurgeryLaser Fiber Delivery Systems878.4810 874.4500 886.4390 884.4550 886.4690IIGEX EWG LLW HQF HHR HQB1CN
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
Start Signature

Dated: April 23, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

Footnotes

1.  Spaulding, 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, 1971:254-274.

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2.  This draft guidance document is available on the CDRH Web site at http//www.fda.gov/​cdrh/​reuse/​1156.pdf.

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3.  Spaulding, 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, 1971:254-274.

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[FR Doc. 03-10413 Filed 4-23-03; 5:03 pm]

BILLING CODE 4160-01-P