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
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