( _.t# U.S. FOOD & DRUG ... -... II 

\,,,.,,-::i_~ ADMINISTRATION 

Waiver to Allow Participation in a Food and Drug Administration 

Advisory Committee 

DATE: January 2, 2024 

TO: Rachel Bressler 

Acting Director, Advisory Committee Oversight and Management Staff 

Office of the Chief Scientist 

FROM: CDR Daniel Bailey, M.S., M.B.A., M.DIV, COR III 

Assistant Director, Committee Management and Planning 

Division of Management Services, Office of Management 

Center for Devices and Radiological Health (CDRH) 

Name of Advisory Committee Meeting Temporary Non-Voting Member: Jeffrey M. Feldman, 

M.D., M.S.E. 

Committee: Anesthesiology and Respiratory Devices Panel (ARTDP) of the Medical Devices 

Advisory Committee (MDAC) 

Meeting date: February 2, 2024 

Description of the Particular Matter to Which the Waiver Applies: 

On February 2, 2024, the Anesthesiology and Respiratory Devices Panel (ARTDP) of the 

Medical Devices Advisory Committee (MDAC) will discuss ongoing concerns that pulse 

oximeters may be less accurate in individuals with darker skin pigmentation. The committee will 

discuss an approach to improve the quality of premarket studies and associated methods used to 

evaluate the performance of pulse oximeters submitted for premarket review, taking into 

consideration a patient’s skin pigmentation and patient-reported race and ethnicity. The 

committee will discuss the type and amount of data that should be provided by manufacturers to 

FDA to evaluate the performance of pulse oximeters submitted for premarket review, including 

prescription and over-the-counter indications, and labeling considerations. 

The topic for this meeting is a particular matter of general applicability (PMGA). 

Type, Nature, and Magnitude of the Financial Interest(s): 

Jeffrey M. Feldman, M.D., M.S.E., is being requested to serve as a temporary non-voting member 

for the ARTDP of the MDAC, which reviews and evaluates data concerning the safety and 

effectiveness of marketed and investigational devices for use in 

U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

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anesthesiology and respiratory therapy and makes appropriate recommendations to the 

Commissioner of Food and Drngs. 

Dr. Feldman reported a financial interest in (6)(4) a health 

sector mutual fund. This fund includes an underl ing asset in fom potentiall 

affected/com etin ulse oximeter films, (6)(4) w 

, representing b (4 

respectively, of the holdings of the fund. The market value of Dr. Feldman's financial interest in 

the fund is between $75,000 and $125,000 as of the writing of this waiver, based on publicly 

available fund infonnation. 

Under a regulato1y exemption issued by the Office of Government Ethics, an employee may 

paii icipate in any paiticulai· matter affecting one or more holdings in a sector mutual fund where 

the disqualifying financial interest in the matter arises because of ownership of an interest in the 

fund and the aggregate market value of interests in all funds in which there is a disqualifying 

financial interest, and which concentrates in the same sector does not exceed $50,000. Because 

Dr. Feldman's financial interests in the above listed sector fund exceeds that ainount, he has a 

disqualifying financial interest based on the fund holdings ofthe above-mentioned fnms. 

In addition, Dr. Feldman's employer has submitted a grant application to the National Institutes 

of Health/National Heaii, Lung, and Blood Institute (NIHINHLBI for a Pros ective 

Observational Reseai·ch ro • ect. The title of the ~ ant is: ""6....,....4____________ _J which is a matter related to the eneral 

issues comin before the Panel. The intent ofthis federall funded J)roject is to (6)(4) .__ 

At present, (b)( 4) 

affected/competing pulse oximeter film"'-~~------------s ai·e lanned device suppliers for evaluation - . Dr. 

Feldman's employer is requesting b) 4 over a b 4 period from the NIHINHLBI for 

the project, but no final decision has been made, and the expected timeframe for the project has 

not been dete1mined. Dr. Feldman will serve as a co-investigator on the project and he is not 

expecting to receive any personal compensation. At this time no funds have been exchanged. 

Basis for Granting the Waiver: 

The upcoming Febrnaiy 2, 2024, meeting ofthe ARTDP will discuss highly specialized issues of 

tremendous public health impo1iance regai·ding pulse oximeters. FDA will pose challenging 

questions to the Panel regai·ding the optimal premai·ket clinical study design and analysis for 

these devices as well as key aspects related to their over-the-counter (OTC) use for medical 

pmposes. Pulse oximeters play a highly impo1i ant role in the assessment and monitoring of 

oxygen saturation in a patient's blood. The devices ai·e routinely used and depended upon by 

health cai·e providers in settings ranging from routine office visits to monitoring ofcritically ill 

patients in the intensive cai·e unit and operating room. Over the past several yeai·s, there has been 

increased recognition and concern regai·ding dispai·ate perfo1mance of these devices ainong 

various groups ofpatients related to skin pigmentation, race, and ethnicity. These perfo1mance 

disparities can adversely impact impo1i ant clinical treatment decisions such as hospital 

adinission and oxygen administration. Thus, it is vital to have the ve1y best clinical expe1is from 
 

 

 

 

 

 

 

 

 

 

 

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specific clinical backgrounds participate in the panel meeting and discuss the most appropriate 

way to address these issues that can result in healthcare inequities. Dr. Feldman possesses a 

unique combination of extensive training and experience in pediatric anesthesiology, research 

experience in patient populations affected by these issues, and training and expertise in medical 

device technology. We believe that any potential conflicts of interest are strongly outweighed by 

the benefit of him sharing his knowledge and judgement during the discussion of FDA’s 

questions at the panel meeting. 

Dr. Feldman has unique qualifications and specialized expertise needed for this 

particular matter. 

Dr. Feldman has specialized expertise needed for this particular matter. Dr. Feldman received his 

medical degree from Albany Medical College and completed his residency in Anesthesiology at 

the University of Florida College of Medicine. Additionally, he completed a fellowship in 

Pediatric Anesthesiology at the Children’s Hospital of Philadelphia (CHOP). He has many years 

of experience in academic medicine across numerous institutions (Yale University, University of 

Pennsylvania, Drexel University, and the University of Florida). He has published more than 70 

research articles, many of which involve the role of medical devices in the monitoring and 

treatment of critically ill patients who would be impacted by the issues being discussed at the 

panel meeting (e.g., low flow ventilation techniques, the challenges related to designing displays 

and alerts for monitoring devices, depth of anesthesia monitoring, etc.). He has an unusual level 

of expertise in evaluating device technology due to his having also received a master’s degree in 

Bioengineering from the University of Pennsylvania. Thus, his broad and highly specialized 

expertise is needed to address the complex issues regarding disparate performance of pulse 

oximeters due to skin pigmentation, race and ethnicity that will play a central role in the meeting. 

There is limited expertise available and it is difficult to locate similarly qualified individuals 

without a disqualifying financial interest. 

As noted above, Dr. Feldman’s expertise in pediatric anesthesiology and medical device design 

and technology, including specialized experience and research in monitoring displays, alarms, 

and monitoring approaches, is without precedent among the many SGEs we have reviewed 

across panels within CDRH and the Center for Drug Evaluation and Research. We have also 

attempted to recruit numerous clinicians with similar broad expertise, particularly in the pediatric 

anesthesiology field, but have been unsuccessful. 

The particular matter is not sensitive 

The issues that will be discussed at the February 2, 2024, panel meeting have been previously 

discussed at a panel meeting in November 2022. FDA will be presenting proposed changes to 

the design and analysis of premarket clinical studies for pulse oximeters largely based on the 

Panel’s prior feedback and recommendations. The issue of disparate performance of pulse 

oximeters related to skin pigmentation, race and ethnicity has been known and described in the 

literature for at least two decades, although it has received increased attention due to the 

increased use of pulse oximetry during the COVID-19 pandemic. While there is some sensitivity 

with respect to the health equity concerns raised by this issue, they do not relate to Dr. Feldman’s 
 

 

 

 

 

 

 

 

 

 

 

 

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clinical activities or background and should not adversely impact his candidacy for participation 

in the panel meeting. 

Dr. Feldman’s expertise in this particular matter is necessary in the interest of public health. 

Dr. Feldman has specialized knowledge and expertise in several critical areas that will be 

discussed by the Panel. First, his knowledge of pediatric anesthesiology will be critical in 

understanding the necessary performance of pulse oximeters for pediatric patients with a variety 

of skin pigmentations and racial/ethnic backgrounds undergoing surgery. He will also 

understand the “form and fit” factors related to the sensor of the pulse oximeter that may 

influence oxygen saturation values, and how best to convey the performance characteristics and 

limitations of pulse oximeters to other clinicians. Additionally, his pediatric background will 

also be important as the role of and labeling for OTC pulse oximeters for medical purposes in 

pediatric patients will also be discussed. His bioengineering expertise will also be useful in 

discussing how the devices can best display information and alerts (if indicated) for users in the 

prescription and OTC device use settings. 

Any potential for a conflict of interest is greatly outweighed by the strong need for Dr. 

Feldman’s expertise in this matter. 

Due to the high public health importance of the device issues being discussed, which could 

impact pediatric as well as adult patients in settings ranging from routine, standard care to the 

highest levels of criticality, it is essential to obtain a broad range of expert feedback and 

recommendations from the Panel regarding premarket clinical study design and analysis as well 

as issues related to OTC marketing of pulse oximeters. Dr. Feldman is uniquely well qualified to 

serve on this Panel due to his many years of training and experience in pediatric anesthesiology 

and his extensive research background and understanding of medical device technology. The 

CDRH staff have endeavored to find others with a similar strong background in these essential 

areas and have been unable to do so. Given the limited time left prior to the panel meeting, we 

believe Dr. Feldman’s participation in the February 2, 2024, meeting will be essential to obtain 

feedback and recommendations on FDA’s panel questions. 

Accordingly, I recommend that you grant Dr. Jeffrey Feldman, a temporary non-voting member 

of the ARTDP of the MDAC, a waiver from the conflict of interest prohibitions of 18 U.S.C. § 

208(a). 

Certification: 

____X___ The individual may participate, pursuant to 18 U.S.C. 208(b)(3) – The need for the 

individual’s services outweighs the potential for a conflict of interest created by the 

financial interest involved. 

Limitations on the Regular Government Employee’s or Special Government Employee’s Ability 

to Act: 
 

 

 

 

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Denied – The individual may not participate. 

/S/ _January 16, 2024 

Rachel Bressler Date 

Acting Director, Advisory Committee Oversight and Management Staff 

Office of the Chief Scientist