03-10413. 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) 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 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.

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.

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.

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  This draft guidance document is available on the CDRH Web site at http//www.fda.gov/​cdrh/​reuse/​1156.pdf.

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.