27
THE EAR, NOSE, AND THROAT DEVICES CLASSIFICATION PANEL OF THE FOOD AND DRUG ADMINISTRATION RALPH
F. NAUNTON, MD
CHICAGO, IlliNOIS
and HARRY R. SAUBERMAN BY INVITATION
SILVER SPRING, MARYLAND
The passage into law in 1976 of the Medical Device Amendments authorized the FDA to regulate the safety and efficacy of medical devices. The effects of this regulation are contrasted with the mode of entry of medical devices onto the market prior to 1976. The structure and operation of Ear, Nose, and Throat Devices Classification Panel is described briefly. Continued input from otolaryngologists and allied professionals is encouraged.
INTRODUCTION IN May of 1976, the Medical Device Amendments were signed into law; this gave the Food and Drug Administration (FDA) the authority of Congress to regulate the "safety and efficacy" of medical devices. The Bureau of Medical Devices was charged with the implementation of these amendments.
Submitted for publication Sept 11, 1978. From the Department of Otolaryngology, University of Chicago (Dr Naunton), and the Bureau of Medical Devices, Food and Drug Administration, Silver Spring, Md (Mr Sauberman). Presented at the 1978 Annual Meeting of the American Academy of Otolaryngology, Las Vegas, Sept 1013. Reprint requests to Chairman of Otolaryngology, University of Chicago, 950 E 59th St (Box 412), Chicago, IL 60637 (Dr Naunton).
Before the amendments were signed, a new medical and surgical device was thought up by a concerned physician, surgeon, researcher, or manufacturer; it was then developed, manufactured, and offered for sale. Usually the inventors were responsible and conscientious and would not offer for sale any device whose dangers outweighed its potential benefits. The manufacturer was under no legal obligation to be specific about the safety and efficacy of his product, which could, therefore, reach the consumer without any assurance of safety, let alone efficacy. Only if a manufacturer made specific claims about a product could he be required to validate those claims. The writers of the amendments recognized the potential dangers inherent in this arrangement and proposed that all medical devices intended for human use be regulated in order to ensure safety and efficacy. Congress did not expect the FDA to eliminate all risks from the use of medical devices, but simply to ensure a satisfactory balance between safety and potential benefits.
IMPLEMENTATION OF THE AMENDMENTS The amendments require that the Secretary of Health, Education, and Welfare obtain medical and technical counselling from advisory panels of experts whose
Oto/aryngol Head Neck Surg 87:27-31 (jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
NAUNTON AND SAUBERMAN
28
immediate task would be to review and classify medical devices. With this intent, the FDA established a number of such panels, one of which is the Ear, Nose, and Throat Devices Classification Panel. In fact, the FDA had been able to anticipate the passage of the Amendments into law and had established advisory panels, including the Ear, Nose, and Throat Panel, two years earlier.
THE EAR, NOSE, AND THROAT DEVICES CLASSIFICATION PANEL The Ear, Nose, and Throat Devices Classification Panel has met many times since 1974 and continues to meet three times each year. Meetings are open to the public. The panel normally comprises seven voting members, including its chairman, selected by the commissioner; members are selected so that the panel will have expertise in otolaryngology and the several other scientific disciplines bordering that area (Table). Two nonvoting members, one an industry representative and one a consumer representative, also sit on the panel. From the administrative and technical viewpoint, the panel is guided by an executive secretary (Harry Sauberman), a professional employee of the FDAwhose training has been in engineering.
PANEl STRUCTURE --_ •...
_--_ _--..,---,._.__._._.. ..
'
----
_-_.. .. ---_.. ,
~,
_-----_ ..•
-~_._-----_._-------_._------_._._--_._--_
• 7 VOTING MEMBERS
• Clinical & Administrative Medicine • Biomedical Engineering • Biological & Physical Science • Other Related Disciplines • 2 NON VOTING MEMBERS
• Consumer Representative • Industry Representative • FDA EXECUTIVE SECRETARY
__._-
..
Figures 1 and 2 show the current and previous membership of the panel; the panel also commonly seeks and receives, either verbally or in writing, the opinions of otolaryngologists, audiologists, speech pathologists, pathologists, manufacturers, and researchers who have developed specific ear, nose, and throat devices. One of the purposes of the panel was accomplished as it reviewed all ear-, nose-, and throat-related devices introduced before 1976. Items were recommended by the panel for categorization into Classes I, II, or III, according to the level of control deemed necessary to ensure safety and efficacy. As a general rule, all devices are classified into the least restrictive class consistent with safety and efficacy, and will only be placed under greater restriction in a higher category when there is a clear need for a greater degree of restriction or control. The exception to this general rule is that implants and life-supporting or life-sustaining devices are generally controlled by the most restrictive category unless there is clear justification for a lesser degree of restriction. The least restrictive category is Class I and requires little more than general controls, including good manufacturing practices. For items placed in this category, however, the FDA can (1) ban a device if it is deemed unsafe or dangerous and (2) require a manufacturer to notify users of risks relating to the item. Many instruments used in the office examination of patients are in Class I (eg, speculi, tuning forks, mirrors). The next restrictive category is Class II (Performance Standards). It is intended for devices requiring more control than a Class I item and for whose performance a standard is either available (eg, hearing aids) or could be written, based on available medical and scientific data (eg, caloric stimulators, facial nerve stimulators).
Oto/aryngol Head Neck Surg 87:27-31 (Jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
ENT DEVICES ClASSIFICATION PANEL
29
EAR, NOSE, 8 THROAT DEVICE CLASSIFICATION PANEL PRESENT MEMBERS: JUERGEN TONNDORF, M.D. CHAIRMAN BYRON J. BAILEY. M.D. RALPH F. NAUNTON, M.D. MARC S. KARLAN. M. D. DAVID J. ANDERSON, PH.D. MARTHA RUBIN, ED. D. RUSSELL L. THOMPSON (INDUSTRY REP,) GEORGIA D. MACKLIN (CONSUMER REP.) CONSUL TANTS: RICHARD L. GOODE, M. D. DAVID E. CROWLEY. PH. D. ROY K. SEDGE, PH. D. M. STUART STRONG. M. D. Fig 1.-Present members and consultants of ENT Device Classification Panel.
EAR, NOSE, a THROAT DEVICE CLASSIFICATION PANEL PREVIOUS MEMBERS: HARRY W. MCCURDY, M. D. RITA B. EISENBERG, SC.-o. JAMES JERGER, PH. D. ARTHUR F. NIEMOELLER. SC. D. F. BLAIR SIMMONS, M. D. GABRIEL F. TUCKER, JR., M. D. WALTER C. MCLEAN, M. D. GEZA J. JAKO, M. D. JEAN L. MCCARREY (CONSUMER REP.) Fig 2.-Previous members of ENT Devices Classification Panel.
Oto/aryngol Head Neck Surg 87:27-31 (Jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
30
NAUNTON AND SAUBERMAN
A device placed in Class II continues to be regulated as a Class I item until the necessary performance standards are written and formally adopted by the FDA. The third and most restrictive category is Class III (Pre-market Approval). All lifesustaining, life-supporting, or implanted devices automatically go into this category unless it is believed that standards or general controls would provide a reaso~able assurance of safety and efficacy. This category also includes devices that are not life-sustaining or supporting for which performance standards would be highly desirable, but for which there is believed to be inadequate medical and scientific data to permit the development of such standards.
RECENT WORK OF THE EAR, NOSE, AND THROAT PANEL The panel has recently recommended that the items shown in Fig 3 be classified into Class II and given high priority in the development of performance standards. It has also recommended that the composite synthetic polymer polytetrafluoroethylene, mixed with vitreous carbon fiber~, and the synthetic polymer polyamide mesh be placed in Class II. It recommended, however, that porous polyethylene, commonly used in middle ear implants, be placed in Class III because there was insufficient information to justify a lower classification. Other items recommended for placement in Class III include (1) endolym-
HIGH PRIORITY ENT DEVICES RECOMMENDED FOR STANDARDS •
ACOUSTIC CHAMBERS
•
•
ACOUSTIC IMPEDANCE TESTERS
AUDITORY EVOKED POTENTIAL DEVICES
•
FACIAL NERVE STIMULATORS·
•
GROUP AND MASTER HEARING AIDS
•
AUDITORY TRAINERS
•
HEARING AID CALIBRATORS
•
HEARING AID ANAYLSIS SYSTEMS
•
AUDIOMETERS
•
AUDIOMETER CALIBRATION SETS
•
CALORIC STIMULATORS
•
NYSTAGMOGRAPH DEVICES
•
CARBON DIOXIDE LASERS
•
EAR PROTECTORS (INSERT) Fig 3.-High priority ENT devices recommended for standards.
Otolaryngol Head Neck Surg 87:27-31 (Jan-feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
ENT DEVICES CLASSIFICATION PANEL phatic shunt tubes with valves, (2) tinnitus maskers, (3) suction antichoking devices, and (4) tympanostomy tubes with semipermeable membranes. The following recent recommendations of the panel will serve further to illustrate its other activities and responsibilities. 1. Labeling for fiberoptic light sources and carriers should include information on the output luminance and on the light transmission characteristics of the fiberoptic carriers. 2. Labeling for surgical saws (electric or pneumatic) should indicate the RPM range and amount of torque generated at the cutting edge and control end of the instrument. Instructions for proper care of the saw and procedures for sterilization should also be provided. 3. Labeling for tracheostomy tube cuffs should indicate the maximum allowable air pressure in the cuff. 4. Labeling for insert-type ear protectors should include a statement of their attenuation characteristics and an indication that proper fitting and sanitary care are required. 5. Tinnitus masking devices should be placed in Class III pending the receipt of additional medical and scientific data concerning patient safety (the panel believed some danger from overstimulation may exist if these devices are used at excessive output levels). 6. Labeling for facial nerve stimulators should indicate that these devices are to be restricted to use under the supervision of medically trained personnel, and standards for nerve stimulators should be developed as soon as possible.
31
NEWLY DEVELOPED EAR, NOSE, AND THROAT DEVICES At this point, much has been written about the panel's responsibilities in the matter of devices already on the market, but nothing is said about devices that will be developed in the future. Whenever a manufacturer is preparing to market a new medical device for human use or a modified version of a device previously classified and marketed, the FDA must be notified of the fact. New or modified devices may then be placed in Class 111 until the FDA. has received adequate information to justify a lower classification and has approved marketing. Alternatively, the FDA may find that the new or modified device is substantially similar to one previously marketed; in this case, the manufacturer will be permitted to market his product under the controls applied to the existing device.
PERFORMANCE STANDARDS Several references have been made to the development and use of performance standards. This is another area in which the FDA has actively sought and continues to encourage input from otolaryngologists and other involved professionals. The development of standards for hearing aids exemplifies this cooperation. The hearing aid standard was developed, over several years, as a result of close liaison between the FDA, the American National Standards Institute or "ANSI" (an organization in which the Academy is strongly represented), and hearing aid manufacturers. More performance standards will be required in the future, and the other work of the Ear, Nose, and Throat Panel must continue with strong and enthusiastic input from otolaryngologists and allied specialists.
Oto/aryngol Head Neck Surg 87:27-31 (jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
THE EAR, NOSE, AND THROAT DEVICES CLASSIFICATION PANEL OF THE FOOD AND DRUG ADMINISTRATION RALPH
F. NAUNTON, MD
CHICAGO, IlliNOIS
and HARRY R. SAUBERMAN BY INVITATION
SILVER SPRING, MARYLAND
The passage into law in 1976 of the Medical Device Amendments authorized the FDA to regulate the safety and efficacy of medical devices. The effects of this regulation are contrasted with the mode of entry of medical devices onto the market prior to 1976. The structure and operation of Ear, Nose, and Throat Devices Classification Panel is described briefly. Continued input from otolaryngologists and allied professionals is encouraged.
INTRODUCTION IN May of 1976, the Medical Device Amendments were signed into law; this gave the Food and Drug Administration (FDA) the authority of Congress to regulate the "safety and efficacy" of medical devices. The Bureau of Medical Devices was charged with the implementation of these amendments.
Submitted for publication Sept 11, 1978. From the Department of Otolaryngology, University of Chicago (Dr Naunton), and the Bureau of Medical Devices, Food and Drug Administration, Silver Spring, Md (Mr Sauberman). Presented at the 1978 Annual Meeting of the American Academy of Otolaryngology, Las Vegas, Sept 1013. Reprint requests to Chairman of Otolaryngology, University of Chicago, 950 E 59th St (Box 412), Chicago, IL 60637 (Dr Naunton).
Before the amendments were signed, a new medical and surgical device was thought up by a concerned physician, surgeon, researcher, or manufacturer; it was then developed, manufactured, and offered for sale. Usually the inventors were responsible and conscientious and would not offer for sale any device whose dangers outweighed its potential benefits. The manufacturer was under no legal obligation to be specific about the safety and efficacy of his product, which could, therefore, reach the consumer without any assurance of safety, let alone efficacy. Only if a manufacturer made specific claims about a product could he be required to validate those claims. The writers of the amendments recognized the potential dangers inherent in this arrangement and proposed that all medical devices intended for human use be regulated in order to ensure safety and efficacy. Congress did not expect the FDA to eliminate all risks from the use of medical devices, but simply to ensure a satisfactory balance between safety and potential benefits.
IMPLEMENTATION OF THE AMENDMENTS The amendments require that the Secretary of Health, Education, and Welfare obtain medical and technical counselling from advisory panels of experts whose
Oto/aryngol Head Neck Surg 87:27-31 (jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
NAUNTON AND SAUBERMAN
28
immediate task would be to review and classify medical devices. With this intent, the FDA established a number of such panels, one of which is the Ear, Nose, and Throat Devices Classification Panel. In fact, the FDA had been able to anticipate the passage of the Amendments into law and had established advisory panels, including the Ear, Nose, and Throat Panel, two years earlier.
THE EAR, NOSE, AND THROAT DEVICES CLASSIFICATION PANEL The Ear, Nose, and Throat Devices Classification Panel has met many times since 1974 and continues to meet three times each year. Meetings are open to the public. The panel normally comprises seven voting members, including its chairman, selected by the commissioner; members are selected so that the panel will have expertise in otolaryngology and the several other scientific disciplines bordering that area (Table). Two nonvoting members, one an industry representative and one a consumer representative, also sit on the panel. From the administrative and technical viewpoint, the panel is guided by an executive secretary (Harry Sauberman), a professional employee of the FDAwhose training has been in engineering.
PANEl STRUCTURE --_ •...
_--_ _--..,---,._.__._._.. ..
'
----
_-_.. .. ---_.. ,
~,
_-----_ ..•
-~_._-----_._-------_._------_._._--_._--_
• 7 VOTING MEMBERS
• Clinical & Administrative Medicine • Biomedical Engineering • Biological & Physical Science • Other Related Disciplines • 2 NON VOTING MEMBERS
• Consumer Representative • Industry Representative • FDA EXECUTIVE SECRETARY
__._-
..
Figures 1 and 2 show the current and previous membership of the panel; the panel also commonly seeks and receives, either verbally or in writing, the opinions of otolaryngologists, audiologists, speech pathologists, pathologists, manufacturers, and researchers who have developed specific ear, nose, and throat devices. One of the purposes of the panel was accomplished as it reviewed all ear-, nose-, and throat-related devices introduced before 1976. Items were recommended by the panel for categorization into Classes I, II, or III, according to the level of control deemed necessary to ensure safety and efficacy. As a general rule, all devices are classified into the least restrictive class consistent with safety and efficacy, and will only be placed under greater restriction in a higher category when there is a clear need for a greater degree of restriction or control. The exception to this general rule is that implants and life-supporting or life-sustaining devices are generally controlled by the most restrictive category unless there is clear justification for a lesser degree of restriction. The least restrictive category is Class I and requires little more than general controls, including good manufacturing practices. For items placed in this category, however, the FDA can (1) ban a device if it is deemed unsafe or dangerous and (2) require a manufacturer to notify users of risks relating to the item. Many instruments used in the office examination of patients are in Class I (eg, speculi, tuning forks, mirrors). The next restrictive category is Class II (Performance Standards). It is intended for devices requiring more control than a Class I item and for whose performance a standard is either available (eg, hearing aids) or could be written, based on available medical and scientific data (eg, caloric stimulators, facial nerve stimulators).
Oto/aryngol Head Neck Surg 87:27-31 (Jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
ENT DEVICES ClASSIFICATION PANEL
29
EAR, NOSE, 8 THROAT DEVICE CLASSIFICATION PANEL PRESENT MEMBERS: JUERGEN TONNDORF, M.D. CHAIRMAN BYRON J. BAILEY. M.D. RALPH F. NAUNTON, M.D. MARC S. KARLAN. M. D. DAVID J. ANDERSON, PH.D. MARTHA RUBIN, ED. D. RUSSELL L. THOMPSON (INDUSTRY REP,) GEORGIA D. MACKLIN (CONSUMER REP.) CONSUL TANTS: RICHARD L. GOODE, M. D. DAVID E. CROWLEY. PH. D. ROY K. SEDGE, PH. D. M. STUART STRONG. M. D. Fig 1.-Present members and consultants of ENT Device Classification Panel.
EAR, NOSE, a THROAT DEVICE CLASSIFICATION PANEL PREVIOUS MEMBERS: HARRY W. MCCURDY, M. D. RITA B. EISENBERG, SC.-o. JAMES JERGER, PH. D. ARTHUR F. NIEMOELLER. SC. D. F. BLAIR SIMMONS, M. D. GABRIEL F. TUCKER, JR., M. D. WALTER C. MCLEAN, M. D. GEZA J. JAKO, M. D. JEAN L. MCCARREY (CONSUMER REP.) Fig 2.-Previous members of ENT Devices Classification Panel.
Oto/aryngol Head Neck Surg 87:27-31 (Jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
30
NAUNTON AND SAUBERMAN
A device placed in Class II continues to be regulated as a Class I item until the necessary performance standards are written and formally adopted by the FDA. The third and most restrictive category is Class III (Pre-market Approval). All lifesustaining, life-supporting, or implanted devices automatically go into this category unless it is believed that standards or general controls would provide a reaso~able assurance of safety and efficacy. This category also includes devices that are not life-sustaining or supporting for which performance standards would be highly desirable, but for which there is believed to be inadequate medical and scientific data to permit the development of such standards.
RECENT WORK OF THE EAR, NOSE, AND THROAT PANEL The panel has recently recommended that the items shown in Fig 3 be classified into Class II and given high priority in the development of performance standards. It has also recommended that the composite synthetic polymer polytetrafluoroethylene, mixed with vitreous carbon fiber~, and the synthetic polymer polyamide mesh be placed in Class II. It recommended, however, that porous polyethylene, commonly used in middle ear implants, be placed in Class III because there was insufficient information to justify a lower classification. Other items recommended for placement in Class III include (1) endolym-
HIGH PRIORITY ENT DEVICES RECOMMENDED FOR STANDARDS •
ACOUSTIC CHAMBERS
•
•
ACOUSTIC IMPEDANCE TESTERS
AUDITORY EVOKED POTENTIAL DEVICES
•
FACIAL NERVE STIMULATORS·
•
GROUP AND MASTER HEARING AIDS
•
AUDITORY TRAINERS
•
HEARING AID CALIBRATORS
•
HEARING AID ANAYLSIS SYSTEMS
•
AUDIOMETERS
•
AUDIOMETER CALIBRATION SETS
•
CALORIC STIMULATORS
•
NYSTAGMOGRAPH DEVICES
•
CARBON DIOXIDE LASERS
•
EAR PROTECTORS (INSERT) Fig 3.-High priority ENT devices recommended for standards.
Otolaryngol Head Neck Surg 87:27-31 (Jan-feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
ENT DEVICES CLASSIFICATION PANEL phatic shunt tubes with valves, (2) tinnitus maskers, (3) suction antichoking devices, and (4) tympanostomy tubes with semipermeable membranes. The following recent recommendations of the panel will serve further to illustrate its other activities and responsibilities. 1. Labeling for fiberoptic light sources and carriers should include information on the output luminance and on the light transmission characteristics of the fiberoptic carriers. 2. Labeling for surgical saws (electric or pneumatic) should indicate the RPM range and amount of torque generated at the cutting edge and control end of the instrument. Instructions for proper care of the saw and procedures for sterilization should also be provided. 3. Labeling for tracheostomy tube cuffs should indicate the maximum allowable air pressure in the cuff. 4. Labeling for insert-type ear protectors should include a statement of their attenuation characteristics and an indication that proper fitting and sanitary care are required. 5. Tinnitus masking devices should be placed in Class III pending the receipt of additional medical and scientific data concerning patient safety (the panel believed some danger from overstimulation may exist if these devices are used at excessive output levels). 6. Labeling for facial nerve stimulators should indicate that these devices are to be restricted to use under the supervision of medically trained personnel, and standards for nerve stimulators should be developed as soon as possible.
31
NEWLY DEVELOPED EAR, NOSE, AND THROAT DEVICES At this point, much has been written about the panel's responsibilities in the matter of devices already on the market, but nothing is said about devices that will be developed in the future. Whenever a manufacturer is preparing to market a new medical device for human use or a modified version of a device previously classified and marketed, the FDA must be notified of the fact. New or modified devices may then be placed in Class 111 until the FDA. has received adequate information to justify a lower classification and has approved marketing. Alternatively, the FDA may find that the new or modified device is substantially similar to one previously marketed; in this case, the manufacturer will be permitted to market his product under the controls applied to the existing device.
PERFORMANCE STANDARDS Several references have been made to the development and use of performance standards. This is another area in which the FDA has actively sought and continues to encourage input from otolaryngologists and other involved professionals. The development of standards for hearing aids exemplifies this cooperation. The hearing aid standard was developed, over several years, as a result of close liaison between the FDA, the American National Standards Institute or "ANSI" (an organization in which the Academy is strongly represented), and hearing aid manufacturers. More performance standards will be required in the future, and the other work of the Ear, Nose, and Throat Panel must continue with strong and enthusiastic input from otolaryngologists and allied specialists.
Oto/aryngol Head Neck Surg 87:27-31 (jan-Feb) 1979 Downloaded from oto.sagepub.com at NANYANG TECH UNIV LIBRARY on June 5, 2016
