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U.S. Department of Health and Human Services

Medical Devices

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Preamendments Class III Strategy (Text Only)

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