Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data
Federal RegisterApr 30, 2003
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0161]
Medical Devices; Reprocessed Single-Use 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 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.
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.
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
the industry.
1
These categories of devices are defined as follows:
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.
(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.
2
This draft guidance document is available on the CDRH Web site at
http//www.fda.gov/cdrh/reuse/1156.pdf.
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
definitions 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.
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.
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 section
Classification name
Product code for Non-reprocessed device
Product code for reprocessed device
Product code name for reprocessed device
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.
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.
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.
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.
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 section
Classification name
Product code for non-reprocessed 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 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 or without introducer).
868.5150
Anesthesia conduction needle
MIA
NMR
Short term spinal needle.
868.5730
Tracheal tube
BTR
NMA
Tracheal tube (with or without connector).
868.5905
Noncontinuous (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.
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 unit 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 (co-axial 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 and accessories uni-directional pump.
878.4300
Implantable clip
FZP
NMJ
Implantable clip.
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, 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.
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 specialty
Device type
Regulation No.
Class
Product code
Risk
1,2,3,3*
Critical/semi-critical/non-critical
Premarket exempt
1
Cardio
Cardiopulmonary Bypass Marker
Unclassified
MAB
1
C
N
2
Cardio
Percutaneous & Operative Transluminal Coronary Angioplasty Catheter (PCTA)
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
Unclassified
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
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
Device, Stabilizer, Heart
870.4500
I
MWS
2
C
Y
22
Cardio
External Vein Stripper
870.4885
II
DWQ
3
C
N
23
Cardio
Compressible Limb Sleeve
870.5800
II
JOW
1
N
N
24
Dental
Bur
872.3240
I
EJL
1
C
Y
25
Dental
Diamond Coated Bur
872.3240
I
EJL
3
C
Y
26
Dental
Diamond Instrument
872.4535
I
DZP
3
C
Y
27
Dental
AC-Powered Bone Saw
872.4120
II
DZH
2
C
N
28
Dental
Manual Bone Drill and Wire Driver
872.4120
II
DZJ
2
C
N
29
Dental
Powered Bone Drill
872.4120
II
DZI
2
C
N
30
Dental
Intraoral Drill
872.4130
I
DZA
1
C
Y
31
Dental
Injection Needle
872.4730
I
DZM
3
C
Y
32
Dental
Metal Orthodontic Bracket
872.5410
I
EJF
3
S
Y
33
Dental
Plastic Orthodontic Bracket
872.5470
II
DYW
3
S
N
34
ENT
Bur
874.4140
I
EQJ
1
C
Y
35
ENT
Diamond Coated Bur
874.4140
I
EQJ
3
C
Y
36
ENT
Microdebrider
874.4140
I
EQJ
3
C
Y
37
ENT
Microsurgical Argon Fiber Optic Laser Cable, For Uses Other Than Otology, Including Laryngology & General Use In Otolarngology
874.4490
II
LMS
1
S
N
38
ENT
Microsurgical Argon Fiber Optic Laser Cable, For Use In Otology
874.4490
II
LXR
1
S
N
39
ENT
Microsurgical Carbon-Dioxide Fiber Optic Laser Cable
874.4500
II
EWG
1
S
N
40
ENT
Bronchoscope Biopsy Forceps (Non-Rigid)
874.4680
II
BWH
3
S
N
41
ENT
Bronchoscope Biopsy Forceps (Rigid)
874.4680
II
JEK
1
S
N
42
Gastro/Urology
Biopsy Forceps Cover
876.1075
I
FFF
1
S
Y
43
Gastro/Urology
Biopsy Instrument
876.1075
II
KNW
3
S
N
44
Gastro/Urology
Biopsy Needle Set
876.1075
II
FCG
3
S
N
45
Gastro/Urology
Biopsy Punch
876.1075
II
FCI
2
S
N
46
Gastro/Urology
Mechanical Biopsy Instrument
876.1075
II
FCF
2
S
N
47
Gastro/Urology
Non-Electric Biopsy Forceps
876.1075
I
FCL
3
S
Y
48
Gastro/Urology
Cytology Brush For Endoscope
876.1500
II
FDX
2
S
N
49
Gastro/Urology
Endoscope Accessories
876.1500
II
KOG
2
S
N
50
Gastro/Urology
Extraction Balloons/Baskets
876.1500
II
KOG
2
S
N
51
Gastro/Urology
Endoscopic Needle
876.1500
II
FBK
3
C
N
52
Gastro/Urology
Simple Pneumoperitoneum Needle
876.1500
II
FHP
3
C
N
53
Gastro/Urology
Spring Loaded Pneumoperitoneum Needle
876.1500
II
FHO
3
C
N
54
Gastro/Urology
Active Electrosurgical Electrode
876.4300
II
FAS
3
S
N
55
Gastro/Urology
Biliary Sphincterotomes
876.5010,
876.1500
II
FGE
3
S
N
56
Gastro/Urology
Electric Biopsy Forceps
876.4300
II
KGE
3
S
N
57
Gastro/Urology
Electrosurgical Endoscopic Unit (With Or Without Accessories)
876.4300
II
KNS
3
S
N
58
Gastro/Urology
Flexible Snare
876.4300
II
FDI
3
S
N
59
Gastro/Urology
Flexible Suction Coagulator Electrode
876.4300
II
FEH
3
S
N
60
Gastro/Urology
Flexible Stone Dislodger
876.4680
II
FGO
3
S
Y
61
Gastro/Urology
Metal Stone Dislodger
876.4680
II
FFL
3
S
Y
62
Gastro/Urology
Needle Holder
876.4730
I
FHQ
1
C
Y
63
Gastro/Urology
Non-Electrical Snare
876.4730
I
FGX
1
S
Y
64
Gastro/Urology
Urological Catheter
876.5130
II
KOD
2
S
N
65
Gastro/Urology
Single Needle Dialysis Set
876.5540
II
LBW, FIE
3
C
N
66
Gastro/Urology
Hemodialysis Blood Circuit Accessories
876.5820
II
KOC
2
S
N
67
Gastro/Urology
Single Needle Dialysis Set
876.5820
II
FIF
3
C
N
68
GE/U
Hemorrhoidal Ligator
876.4400
II
FHN
2
C
N
69
General
Hospital
Implanted, Programmable Infusion Pump
Post-amendment
III
LKK
3
C
N
70
General
Hospital
Needle Destruction Device
Post-amendment
III
MTV
1
N
N
71
General
Hospital
Non-Powered Flotation Therapy Mattress
880.5150
I
IKY
2
N
Y
72
General
Hospital
Non AC-Powered Patient Lift
880.5510
I
FSA
2
N
Y
73
General
Hospital
Alternating Pressure Air Flotation Mattress
880.5550
II
FNM
1
N
Y
74
General
Hospital
Temperature Regulated Water Mattress
880.5560
I
FOH
2
N
Y
75
General
Hospital
Hypodermic Single Lumen Needle
880.5570
II
FMI
3
C
N
76
General
Hospital
Piston Syringe
880.5860
II
FMF
3
C
N
77
General
Hospital
Mattress Cover (Medical Purposes)
880.6190
I
FMW
2
N
Y
78
General
Hospital
Disposable Medical Scissors
880.6820
I
JOK
1
N
Y
79
General
Hospital
Irrigating Syringe
880.6960
I
KYZ,
KYY
1
C
Y
80
Infection
Control
Surgical Gowns
878.4040
II
FYA
1
C
N
81
Lab
Blood Lancet
878.4800
I
FMK
1
C
Y
82
Neuro
Clip Forming/Cutting Instrument,
882.4190
I
HBS
3*
C
Y
83
Neuro
Drills, Burrs, Trephines & Accessories (Manual)
882.4300
II
HBG
3*
C
N
84
Neuro
Drills, Burrs, Trephines & Accessories (Compound, Powered)
882.4305
II
HBF
3*
C
N
85
Neuro
Drills, Burrs, Trephines & Accessories (Simple, Powered)
882.4310
II
HBE
3*
C
N
86
OB/GYN
Oocyte aspiration needle
Unclassified
II
MHK
3
C
N
87
OB/GYN
Laparoscope Accessories
884.1720
I
HET
2
C
Y
88
OB/GYN
Laparoscope Accessories
884.1720
II
HET
3
C
N
89
OB/GYN
Laparoscopic Dissectors
884.1720
I
HET
2
C
Y
90
OB/GYN
Laparoscopic Graspers
884.1720
I
HET
2
C
Y
91
OB/GYN
Laparoscopic Scissors
884.1720
I
HET
2
C
Y
92
OB/GYN
Insufflator Accessories (tubing, Verres needle, kits)
884.1730
II
HIF
3
C
Y
93
OB/GYN
Laparoscopic Insufflator
884.1730
II
HIF
2
N
N
94
OB/GYN
Endoscopic Electrocautery And Accessories
884.4100
II
HIM
2
N
N
95
OB/GYN
Gynecologic Electrocautery (And Accessories)
884.4120
II
HGI
2
N
N
96
OB/GYN
Endoscopic Bipolar Coagulator-Cutter (And Accessories)
884.4150
II
HIN
2
N
N
97
OB/GYN
Culdoscopic Coagulator (And Accessories)
884.4160
II
HFI
2
N
N
98
OB/GYN
Endoscopic Unipolar Coagulator-Cutter (And Accessories)
884.4160
II
KNF
2
N
N
99
OB/GYN
Hysteroscopic Coagulator (And Accessories)
884.4160
II
HFH
2
N
N
100
OB/GYN
Unipolar Laparoscopic Coagulator (And Accessories)
884.4160
II
HFG
2
N
N
101
OB/GYN
Episiotomy Scissors
884.4520
I
HDK
1
C
Y
102
OB/GYN
Umbilical Scissors
884.4520
I
HDJ
1
C
Y
103
OB/GYN
Biopsy Forceps
884.4530
I
HFB
3
C
Y
104
OB/GYN
Assisted reproduction needle
884.6100
II
MQE
3
C
N
105
Ophthalmic
Endoilluminator
876.1500
II
MPA
3*
C
N
106
Ophthalmic
Surgical Drapes
878.4370
II
KKX
2
C
N
107
Ophthalmic
Ophthalmic Knife
886.4350
I
HNN
3
C
Y
108
Ophthalmic
Keratome Blade
886.4370
Inot exempt
HMY,
HNO
3
C
N
109
Ophthalmic
Phacoemulsification Needle
886.4670
II
HQC
3
C
N
110
Ophthalmic
Phacoemulsification/Phacofragmentation Fluidic
886.4670
II
MUS
2
C
N
111
Ophthalmic
Phacofragmentation Unit
886.4670
II
HQC
1
N
N
112
Ortho
Saw Blades
878.4820
I
GFA,
DWH,
GEY,
GET
1
C
Y
113
Ortho
Surgical Drills
878.4820
I
GEY,
GET
1
C
Y
114
Ortho
Arthroscope accessories
888.1100
II
HRX
2
C
Y
115
Ortho
Bone Tap
888.4540
I
HWX
1
C
Y
116
Ortho
Burr
888.4540
I
HTT
1
C
Y
117
Ortho
Carpal Tunnel Blade
888.4540
I
LXH
2
C
Y
118
Ortho
Countersink
888.4540
I
HWW
1
C
Y
119
Ortho
Drill Bit
888.4540
I
HTW
1
C
Y
120
Ortho
Knife
888.4540
I
HTS
1
C
Y
121
Ortho
Manual Surgical Instrument
888.4540
I
LXH
1
C
Y
122
Ortho
Needle Holder
888.4540
I
HXK
1
C
Y
123
Ortho
Reamer
888.4540
I
HTO
1
C
Y
124
Ortho
Rongeur
888.4540
I
HTX
1
C
Y
125
Ortho
Scissors
888.4540
I
HRR
1
C
Y
126
Ortho
Staple Driver
888.4540
I
HXJ
1
C
Y
127
Ortho
Trephine
888.4540
I
HWK
1
C
Y
128
Ortho
Flexible Reamers/Drills
886.4070
878.4820
I
GEY,
HRG
1
C
Y
129
Ortho
External Fixation Frame
888.3040
888.3030
II
JEC
KTW
KTT
2
N
N
130
Physical
Medicine
Non-Heating Lamp for Adjunctive Use Inpatient Therapy
Unclassified
NHN
1
N
N
131
Physical
Medicine
Electrode Cable,
890.1175
II
IKD
1
N
Y
132
Physical
Medicine
External Limb Component, Hip Joint
890.3420
I
ISL
2
N
Y
133
Physical
Medicine
External Limb Component, Knee Joint
890.3420
I
ISY
2
N
Y
134
Physical
Medicine
External Limb Component, Mechanical Wrist
890.3420
I
ISZ
2
N
Y
135
Physical
Medicine
External Limb Component, Shoulder Joint
890.3420
I
IQQ
2
N
Y
136
Plastic
Surgery
Stapler
878.4800
I
GAG,
GEF,
FHM,
HBT
2
C
Y
137
Radiology
Isotope Needle
892.5730
II
IWF
3
C
N
138
Resp
Endotracheal Tube Changer
Unclassified
III
LNZ
3
C
N
139
Resp
Anesthesia conduction needle
868.5150
II
BSP
3
C
N
140
Resp
Short term spinal needle
868.5150
II
MIA
3
C
N
141
Resp
Respiratory Therapy And Anesthesia Breathing Circuits
868.5240
I
CAI
2
S
Y
142
Resp
Oral And Nasal Catheters
868.5350
I
BZB
1
C
Y
143
Resp
Gas Masks
868.5550
I
BSJ
1
S
Y
144
Resp
Breathing Mouthpiece
868.5620
I
BYP
1
N
Y
145
Resp
Tracheal Tube
868.5730
II
BTR
3
C
N
146
Resp
Airway Connector
868.5810
I
BZA
2
S
Y
147
Resp
CPAP Mask
868.5905
II
BZD
3
S
N
148
Resp
Emergency Manual Resuscitator
868.5915
II
BTM
2
S
N
149
Resp
Tracheobronchial Suction Catheter
868.6810
I
BSY
3
S
Y
150
Surgery
AC-powered Orthopedic Instrument and accessories
Unclassified
HWE
2
C
N
151
Surgery
Breast Implant Mammary Sizer
Unclassified
MRD
1
C
N
152
Surgery
Ultrasonic Surgical Instrument
Unclassified
LFL
3
C
N
153
Surgery
Trocar
874.4420
I
KAB,
KBG,
KCI
3
C
Y
154
Surgery
Endoscopic Blades
876.1500
II
GCP,
GCR
2
C
N
155
Surgery
Endoscopic Guidewires
876.1500
II
GCP,
GCR
1
C
N
156
Surgery
Inflatable External Extremity Splint
878.3900
I
FZF
1
N
Y
157
Surgery
Noninflatable External Extremity Splint
878.3910
I
FYH
1
N
Y
158
Surgery
Catheter needle
878.4200
I
GCB
3
C
Y
159
Surgery
Implantable Clip
878.4300
II
FZP
3
C
N
160
Surgery
Electrosurgical And Coagulation Unit With Accessories
878.4400
II
BWA
2
C
N
161
Surgery
Electrosurgical Apparatus
878.4400
II
HAM
2
C
N
162
Surgery
Electrosurgical Cutting & Coagulation Device & Accessories
878.4400
II
GEI
2
C
N
163
Surgery
Electrosurgical Device
878.4400
II
DWG
2
C
N
164
Surgery
Electrosurgical Electrode
878.4400
II
JOS
2
C
N
165
Surgery
Implantable Staple, Clamp, Clip for Suturing Apparatus
878.4750
II
GDW
3
C
N
166
Surgery
Percutaneous biopsy device
878.4800
I
MJG
3
C
Y
167
Surgery
Gastro-Urology needle
878.4800
I
FHR
3
C
Y
168
Surgery
Aspiration and injection needle
878.4800
I
GAA
3
C
Y
169
Surgery
Biopsy Brush
878.4800
I
GEE
1
C
Y
170
Surgery
Blood Lancet
878.4800
I
FMK
1
C
Y
171
Surgery
Bone Hook
878.4800
I
KIK
1
C
Y
172
Surgery
Cardiovascular Biopsy Needle
878.4800
I
DWO
3
C
Y
173
Surgery
Clamp
878.4800
I
GDJ
1
C
Y
174
Surgery
Clamp
878.4800
I
HXD
1
C
Y
175
Surgery
Curette
878.4800
I
HTF
1
C
Y
176
Surgery
Disposable Surgical Instrument
878.4800
I
KDC
1
C
Y
177
Surgery
Disposable Vein Stripper
878.4800
I
GAJ
1
C
Y
178
Surgery
Dissector
878.4800
I
GDI
1
C
Y
179
Surgery
Forceps
878.4800
I
GEN
2
C
Y
180
Surgery
Forceps
878.4800
I
HTD
2
C
Y
181
Surgery
Gouge
878.4800
I
GDH
1
C
Y
182
Surgery
Hemostatic Clip Applier
878.4800
I
HBT
2
C
Y
183
Surgery
Hook
878.4800
I
GDG
1
C
Y
184
Surgery
Manual Instrument
878.4800
I
MDM,
MDW
1
C
Y
185
Surgery
Manual Retractor
878.4800
I
GZW
1
C
Y
186
Surgery
Manual Saw And Accessories
878.4800
I
GDR
HAC
1
C
Y
187
Surgery
Manual Saw And Accessories
878.4800
I
HAC
1
C
Y
188
Surgery
Manual Surgical Chisel
878.4800
I
FZO
1
C
Y
189
Surgery
Mastoid Chisel
878.4800
I
JYD
1
C
Y
190
Surgery
Orthopedic Cutting Instrument
878.4800
I
HTZ
1
C
Y
191
Surgery
Orthopedic Spatula
878.4800
I
HXR
1
C
Y
192
Surgery
Osteotome
878.4800
I
HWM
1
C
Y
193
Surgery
Rasp
878.4800
I
GAC
1
C
Y
194
Surgery
Rasp
878.4800
I
HTR
1
C
Y
195
Surgery
Retractor
878.4800
I
GAD
1
C
Y
196
Surgery
Retractor
878.4800
I
HXM
1
C
Y
197
Surgery
Saw
878.4800
I
HSO
1
C
Y
198
Surgery
Scalpel Blade
878.4800
I
GES
1
C
Y
199
Surgery
Scalpel Handle
878.4800
I
GDZ
1
C
Y
200
Surgery
Scissors
878.4800
I
LRW
1
C
Y
201
Surgery
Snare
878.4800
I
GAE
1
C
Y
202
Surgery
Spatula
878.4800
I
GAF
1
C
Y
203
Surgery
Staple Applier
878.4800
I
GEF
2
C
Y
204
Surgery
Stapler
878.4800
I
GAG
2
C
Y
205
Surgery
Stomach And Intestinal Suturing Apparatus
878.4800
I
FHM
2
C
Y
206
Surgery
Surgical Curette
878.4800
I
FZS
1
C
Y
207
Surgery
Surgical Cutter
878.4800
I
FZT
1
C
Y
208
Surgery
Surgical Knife
878.4800
I
EMF
1
S
Y
209
Surgery
Laser Powered Instrument
878.4810
II
GEX
2
C
N
210
Surgery
Ac-Powered Motor
878.4820
I
GEY
2
C
Y
211
Surgery
Bit
878.4820
I
GFG
1
C
Y
212
Surgery
Bur
878.4820
I
GFF,
GEY
1
C
Y
213
Surgery
Cardiovascular Surgical Saw Blade
878.4820
I
DWH
1
C
Y
214
Surgery
Chisel (Osteotome)
878.4820
I
KDG
1
C
Y
215
Surgery
Dermatome
878.4820
I
GFD
1
C
Y
216
Surgery
Electrically Powered Saw
878.4820
I
DWI
2
C
Y
217
Surgery
Pneumatic Powered Motor
878.4820
I
GET
2
C
Y
218
Surgery
Pneumatically Powered Saw
878.4820
I
KFK
2
C
Y
219
Surgery
Powered Saw And Accessories
878.4820
I
HAB
2
C
Y
220
Surgery
Saw Blade
878.4820
I
GFA
1
C
Y
221
Surgery
Nonpneumatic Tourniquet
878.5900
I
GAX
1
N
Y
222
Surgery
Pneumatic Tourniquet
878.5910
I
KCY
1
N
Y
223
Surgery
Enodoscopic Staplers
888.4540
I
HXJ
2
C
Y
224
Surgery
Trocar
876.1500
870.1390
II
GCJ,
DRC
3
C
N
225
Surgery
Surgical Cutting Accessories
878.4800,
874.4420
I
GDZ,
GDX,
GES,
KBQ,
KAS
2
C
Y
226
Surgery
Electrosurgical Electrodes/Handles/Pencils
876.4300
878.4400
II
HAM,
GEI,
FAS
2
C
N
227
Surgery
Scissor Tips
878.4800,
884.4520,
874.4420
I
LRW,
HDK,
HDJ,
JZB,
KBD
2
C
Y
228
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
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
Dated: April 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10413 Filed 4-23-03; 5:03 pm]
BILLING CODE 4160-01-P
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.