MEMORANDUM Date: April 19, 1994 From: Acting Director, Office of Device Evaluation Subject: Preamendments Class III Strategy To: ODE Division Directors I. Purpose This document provides a strategy for implementation of Safe Medical Devices Act of 1990 mandated activities for preamendments Class III devices. II. Background The 1976 amendments did not immediately subject preamendments devices classified in class III to the premarket approval process. The Act requires FDA to publish 515(b) regulations directing the submission of premarket approval applications for preamendments class III devices. The 515(b) process involves the publication of two Federal Register notices, the Proposed Rule and the Final Rule. The 515(b) Proposed Rule announces FDA's intention to call for PMAs, lists the issues to be addressed in PMA submissions, states a deadline for the receipt of comments, and affords an opportunity to request reclassification. The Final Rule addresses any comments received, repeats the issues to be addressed in PMA submissions, and sets a deadline for the submission of Premarket Approval Applications (PMA) or Investigational Device Exemptions (IDE) of not more than 90 days after the date of publication. At that time, any manufacturer with neither PMA nor IDE must cease distribution of the device. The 1976 Act did not allow a 515(b) regulation to require submission of a PMA for a device until 30 months after the device is classified in class III, or 90 days after the 515(b) regulation is published, whichever is later. Since the last classification regulations were published in 1987, the thirty month period has elapsed for all preamendments Class III devices. The Safe Medical Device Act of 1990's (SMDA's) new section 515(i) requires FDA to order industry submission of a summary of and a citation to any information known or otherwise available to the manufacturer, including adverse safety and effectiveness information, for preamendments class III devices not yet subject to a 515(b) final order and to reconsider their classification in light of redefinition of class II. The Safe Medical Devices Act of 1990 (SMDA) revised the definition of class II to include devices for which "general controls" by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish "special controls", rather than to establish "performance standards" as had been required by the 1976 Act. SMDA also directs FDA to revise the classification of such preamendments class III devices into class I or class II or require the device to remain in class III; and directs FDA to issue a schedule for 515(b) rulemaking within 12 months of publication of a regulation retaining a device in class III. However SMDA does not prevent the FDA from proceeding immediately to section 515(b) rulemaking on specific devices, in the interest of public health, independent of the 515(i) process. ODE Division Directors Page In light of these SMDA provisions and FDA resources, the 117 preamendments class III devices on which FDA has not initiated any action have been grouped as follows: Group 3 includes 42 devices that are not presently considered candidates for reclassification. FDA believes these devices are in commercial distribution and will require submission of PMAs in the near future. Group 2 includes 31 devices that the FDA believes have a high potential for reclassification into class II. Group 1 includes 44 devices which have fallen into disuse or limited use. FDA believes that rulemaking under section 515(b) of the act will be unlikely to result in viable PMAs or reclassification petitions. III. Procedure The grouping and prioritization of preamendments class III devices facilitates the following achievable SMDA activities by December 1, 1995, listed in the order of endeavor: A: High Priority Group 3Devices CDRH will initiate 515(b) rulemaking for fifteen high priority Group 3 devices over the next three years according to the schedule presented in Appendix A. High priority Group 3 devices are those determined currently to present a unreasonably high risk to public health because significant issues of safety and/or effectiveness are not being resolved or, to the best of FDA's knowledge, have little probability of being resolved . The schedule indicates the year of publication of the section 515(b) proposed rule for a device. The timetable for publication of each final rule will have to be based upon specific data needs, comments received, and the existence (if any) of reclassification petitions to be reviewed. These devices are not presently considered candidates for reclassification. The high priority preamendments class III list and schedule is presented in Appendix A. B. Remaining Group 3 Devices CDRH will also issue, in 1994, a section 515(i) order for the remaining twenty-seven Group 3 devices and pursue the same course of evaluation and prioritization described below in section C. The prioritization will result in a schedule determined by the information received. Although these remaining Group 3 devices are not presently considered candidates for reclassification, FDA's evaluation of the data submitted in responseto the 515(i) order will include an assessment of whether one or more of these devices should be moved to Group 2. The continued marketing of the remaining Group 3 devices pending this evaluation does not present as great a risk to the public health in the light of FDA's current knowledge and experience with the devices. The remaining Group 3 devices are listed in Appendix B. ODE Division Directors Page C. Group 2 Devices CDRH will issue, in 1994, a section 515(i) order requiring manufacturers to submit all safety and effectiveness information available or known to them including adverse information for all Group 2 devices. All thirty-one Group 2 devices are considered strong candidates for reclassification. Group 2 includes devices for which existing questions of safety and/or effectiveness that have been or can be answered by information already obtained or being obtained by manufacturers. SMDA modified the definition of Class II devices, as noted above, to rely upon "special controls" to provide reasonable assurance of safety and effectiveness. "Special controls" are defined by SMDA to include performance standards, postmarket surveillance, patient registries, guidelines (including guidelines for the submission of clinical data in premarket notification submissions, known as 510(k)s), recommendations, and other appropriate actions. The SMDA modified definition of Class II together with increased experience with the device may provide grounds for reclassification.The schedule for Group 2 devices is listed in Appendix C. CDRH will complete review and evaluation of the safety and effectiveness information obtained under the 515(i) order. Assignment of devices into groups and prioritization for 515(b) rulemaking will be revised accordingly. CDRH will then proceed with rulemaking to reclassify devices or retain them in class III and revising the schedule of section 515(b) rulemaking for those devices retained in class III. D. Group 1 Devices CDRH will propose section 515(b) rulemaking in 1994 for a group of forty-four devices which have fallen into disuse, designated as group 1. Group 1 includes devices that raise significant questions of safety and/or effectiveness but are rarely in current use. All forty-four devices will be included in the same 515(b) proposed rule document. Group 1 devices are listed in Appendix D. E. Devices from Prior Federal Register Priority Lists CDRH will complete 515(b) rulemaking and the review of reclassification petitions and PMAs for the devices identified as high priority devices in the Uline_beginFederalUline_end Uline_beginRegisterUline_end of September 6, 1983 (48/FR/40272) and the Uline_beginFederalUline_end Uline_beginRegisterUline_end of January 6, 1989 (54/FR/550) which have not been reevaluated and placed in one of the three groups. Two devices listed in the 1983 notice have been grouped into Group 3. Ten devices listed in the 1989 FR notice are now included in Group 1, seven are in Group 3, and eight are in Group 2. The Final Rule (preceded by a proposed rule) has been published and 20 PMAs have been received for 8 of the devices listed in both FR notices. Nine additional proposed rules have been published resulting in seven reclassification petitions. Two of the listed devices have been reclassified. See Appendix E. Susan Alpert, M.D., Ph.D. APPENDIX A: High Priority Group 3 Devices 1994 872.3540 OTC denture cushion or pad 872.3570 OTC denture repair kit 872.6730 Endodontic dry heat sterilizer 876.5280 Implanted mechanical/hydraulic urinary contingence device 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prothesis 890.5290 Shortwave diathermy 1995 872.3600 Partially fabricated denture kit 888.3410 Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis 890.5275 Microwave diathermy 1996 888.3150 Elbow joint metal/metal or metal/polymer constrained cemented prosthesis 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis 890.5300 Ultrasonic diathermy 890.5525 Iontophoresis device 890.5860 Ultrasound and muscle stimulator Appendix B: Remaining Group 3 Devices 868.2450 Lung Water Monitor 868.2500 Cutaneous Oxygen Monitor 868.5610 Membrane Lung for long term pulmonary support 870.1025 Arrythmia detector and alarm 870.3300 Arterial embolization device 870.3375 Cardiovascular intravascular filter 870.3450 Vascular graft prosthesis of less than 6mm diameter 870.3535 Intra-aortic Balloon and Control System 870.3600 External Pacemaker Pulse Generator 870.3610 Implantable Pacemaker Pulse Generator 870.3700 Pacemaker programmers 870.3800 Annoloplasty Ring 870.4230 Cardiopulmonary Bypass Defoamer 870.5225 External Counter-Pulsating Device 870.5550 External Transcutaneous Cardiac Pacemaker (noninvasive) 874.3400 Tinnitus Masker 874.3930 Tympanostomy Tube with Semi-Permeable Membrane 874.5350 Suction Antichoke Device 874.5370 Tongs Antichoke Device 876.5870 Sorbent Hemoperfusion system 876.5955 Peritoneo-venous Shunt 882.1790 Ocular Plethysmograph 882.5860 Implanted neuromuscular stimulator 882.5950 Artificial embolization device 884.5940 Powered Muscle Vaginal Stimulator for Therapeutic Use 886.3400 Keratoprosthesis 890.3890 Stair Climbing Wheelchair APPENDIX C: Group 2 1995 864.7250 Erythropoietin Assay 864.7300 Fibrin Monomer Paracoagulation Test 876.3630 Penile Rigidity Implant 878.5360 Tweezer-type Epilator 884.1060 Endometrial Aspirator 884.1100 Endometrial Brush 884.1185 Endometrial Washer 886.3920 Eye Valve Implants 1996 866.3305 Herpes Simplex Virus Serological Reagents 866.3510 Rubella Virus Serological Reagents 870.3620 Pacemaker Lead Adaptor 872.6080 Airbrush 876.4480 Electrohydraulic Lithotriptor 878.3610 Esophageal Prosthesis 878.3720 Tracheal Prosthesis 884.4100 Endoscopic Electrocautery and Accessories 884.4150 Bipolar Endoscopic Coagulator-Cutter and Accessories 1997 868.1150 Indwelling Blood Carbon Dioxide Partial Pressure Analyzer 868.1170 Indwelling Blood Hydrogen Ion Concentration Analyzer 868.1200 Indwelling Blood Oxygen Partial Pressure Analyzer 870.3680 Cardiovascular Permanent Pacemaker Electrodes 870.4260 Cardiopulmonary Bypass Arterial Line Blood Filter 870.4350 Cardiopulmonary Bypass Oxygenator 876.5860 High Permeability Hemodialysis system 878.5650 Topical 02 Chamber 882.5940 Electroconvulsive Therapy Device 888.3660 Shoulder Semi-constrained 1998 870.3710 Pacemaker Repair or Replacement Material 870.4320 Cardiopulmonary Bypass Pulsatile Flow Generator 870.5200 External Cardiac Compressor 876.5540 Implanted Blood Access Device APPENDIX D: Group 1 Devices 864.5220 Automated differential cell counter (intended for uses other than to flag or identify specimens containing abnormal blood cells) 868.5400 Electroanesthesia apparatus 870.1350 Catheter balloon repair kit 870.1360 Trace microsphere 870.3850 Carotid sinus nerve stimulator 870.3545 Ventricular bypass (assist) device 870.5300 High energy DC-defibrillator (including paddles) 872.3400 Karaya and 12% or more sodium borate with and without acacia denture adhesive 872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive 872.3480 Polyacrylamide polymer (modified cationic) denture adhesive 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive 872.3560 OTC denture reliner 872.3820 Root canal filling resin if chloroform is used as an ingredient in the device 876.5220 Colonic irrigation system for uses other than colon cleansing when medically indicated such as before radiological or endoscopic examinations 876.5270 Implanted electrical urinary continence device 880.5760 Chemical cold pack snakebite kit 882.1825 Rheoencephalograph 882.5150 Intravascular occluding catheter 882.5850 Implanted spinal cord stimulator for bladder evacuation 884.2050 Obstetric data analyzer 884.2620 Fetal electroencephalographic monitor 884.2685 Fetal scalp clip electrode and applicator 884.4250 Expandable cervical dilator 884.4270 Vibratory cervical dilator 884.5050 Metreurynter-balloon abortion system 884.5225 Abdominal decompression chamber 888.3120 Ankle joint metal/polymer non-constrained cemented prothesis 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis 888.3200 Finger joint metal/metal constrained uncemented prosthesis 888.3210 Finger joint metal/metal constrained cemented prothesis 888.3220 Finger joint metal/polymer constrained cemented prosthesis 888.3300 Hip joint metal constrained cemented or uncemented prosthesis 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis 888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis 888.3480 Knee joint femorotibial metallic constrained cemented prosthesis 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis 888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis 888.3790 Wrist joint metal constrained cemented prosthesis 890.3610 Rigid pneumatic structure orthosis APPENDIX E: Status of devices listed in the Federal Register of September 6, 1983 (48/FR/40272) and the Federal Register of January 6, 1989 (54/FR/550). Devices listed in 48/FR/40272 CFR Name of Device Status PMAs Received, Approved 864.5220 Automated Differential Reclassified 06/8/90 Cell Counter 864.5680 Automated Heparin Analyzer Reclassified 10/4/93 864.9245 Automated Blood Cell Separator 515(b) Prop. 02/19/88 (CBER Review) 870.3925 Replacement Heart Valve 515(b) Final (5/13/87) 5 R,4 A 870.3610 Implantable Pacemaker Pulse Reevaluated, Group 3 Generator 870.3700 Pacemaker Programmer Reevaluated, Group 3 880.5130 Infant Radiant Warmer 515(b) Prop. (1/15/86) Reclassification Pet. Pending 882.5840 Implanted Intracerebral/ 515(b) Final (3/01/89) 2 R,2 W Subcortical Stimulator for Pain Relief 882.5820 Implanted Cerebellar Stimulator 515(b) Final (6/28/84) 0 R 882.5830 Implanted Diaphragmatic/Phrenic 515(b) Final (4/08/86) 1 R,1 A Nerve Stimulator 884.1600 Transabdominal Amnioscope 515(b) Final (1/29/87) 0 R (Fetoscope) and Accessories 884.5360 Contraceptive Intrauterine 515(b) Final (8/04/86) 0 R Device (IUD) and Introducer 884.5380 Contraceptive Tubal Occlusion 515(b) Final (12/31/87 2 R,1 A Device and Introducer Devices listed in 54/FR/550 CFR Device Status PMAs Received Approved 866.3305 Herpes Simplex Virus Serological Group 2 Reagents 866.3510 Rubella Virus Serological Group 2 Reagents 868.5400 Electroanesthesia apparatus Group 1 868.5610 Membrane lung for long-term Group 3 pulmonary support 870.3450 Vascular graft prostheses of Group 3 less than 6 millimeters diameter 870.3535 Intra-aortic balloon and control Group 3 system 872.3640 Endosseous implant 515(b) Prop.(12/7/89) Reclassification Pet. Pending 872.6730 Endodontic dry heat High Priority Group 3 sterilizer 874.3850 Endolymphatic Shunt Tube 515(b) Prop.(05/4/90) with valve Reclassification Pet. Pending 876.3750 Testicular Prosthesis 515(b) Prop.(01/8/93) 876.4480 Electrohydraulic lithotriptor Group 2 878.3530 Silicone Inflatable Breast 515(b) Prop.(01/8/93) Implants 878.3540 Silicone gel-filled Breast 515(b) Final (7/9/91) 10 R Prosthesis 880.5760 Chemical cold pack snakebite Group 1 kit 882.5800 Cranial electrotherapy stimulator 515(b) Prop. (3/31/93) Reclassification Pets. Pending 884.1185 Endometrial Washer Group 2 884.4100 Endoscopic Electrocautery and Group 2 accessories 884.5940 Powered Muscle Vaginal Stimulator Group 2 for Therapeutic Use 886.3400 Keratoprosthesis Group 3 CFR Device Status PMAs Received Approved 886.3920 Eye valve implant Group 2 888.3480 Knee joint femorotibial metallic Group 1 constrained cemented prosthesis 888.3540 Knee joint patellofemoral Group 1 polymer/metal semi-constrained cemented prosthesis 888.3550 Knee joint patellofemorotibial Group 1 polymer/metal/metal constrained cemented prosthesis 888.3570 Knee joint femoral (hemi-knee) Group 1 metallic uncemented prosthesis 888.3580 Knee joint patellar (hemi-knee) Group 1 metallic resurfacing uncemented prosthesis 888.3640 Shoulder joint metal/metal or Group 1 metal/polymer constrained cemented prosthesis 888.3650 Shoulder joint metal/polymer High Priority Group 3 semi-constrained cemented prosthesis 888.3660 Shoulder joint metal/polymer Group 2 semi-constrained cemented prosthesis 888.3680 Shoulder joint glenoid (hemi- Group 1 shoulder) metallic cemented prosthesis 890.3610 Rigid pneumatic structure Group 1 orthosis 890.3890 Stair-climbing wheelchair Group 3 Not identified in Federal Register Notice of Intent CFR Device Status PMAs 870.4360 Nonroller-type Cardiopulmonary 515(b) Prop. (7/06/93) Bypass Blood Pump Reclassification Pet. Pending 876.3350 Penile Inflatable Implant 515(b) Prop. (4/28/93) Pending
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