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Marketing Clearance of Diagnostic 

Ultrasound Systems and 

Transducers

Shahram Vaezy, Ph.D.

Biomedical Engineer

Division of Radiological Health

Office of Health and Technology 7

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

August 22, 2019
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o Objectives and Background

o Highlights of the Final Guidance Document 

o Scope

o Compliance Policy

o Transducer Element Check

o Updated Consensus Standards and Guidance Documents

o Key Take-Aways 

o Examples of Compliance Policy Applications

o Resources and Questions 

Agenda
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Objectives

o Understand the regulatory history of diagnostic ultrasound devices

o Become familiar with the landscape of ultrasound industry, and 

understand the recent technological advancements

o Understand the difference between the previous final guidance 

document issued in 2008 and the revised guidance document, 

published June 27, 2019: https://www.fda.gov/media/71100/download

o Become familiar with the new regulatory evaluation
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o Diagnostic ultrasound is a pre-amendment device

o Most diagnostic ultrasound devices receive marketing clearance from the 

FDA through the 510(k) process

o The FDA issued the first diagnostic ultrasound guidance in mid-1980’s 

o Next guidance about diagnostic ultrasound devices version was issued Sept. 

9, 2008

o On June 27, 2019, the FDA issued a revised final guidance: “Marketing 

Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for 

Industry and Food and Drug Administration Staff”

Background
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o Compliance Policy: The FDA does not intend to enforce compliance 

with the 510(k) requirement for certain modified ultrasound and 

transducer devices (that have already obtained an initial 510(k) 

clearance) when certain conditions apply

o Transducer Element Check: Integrated tests of transducer performance 

each time a transducer is connected to the main system or activated

o Updated Consensus Standards

o Updated FDA Guidance Documents

Final Guidance Document Highlights
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• This guidance:

o Supersedes the FDA’s 2008 guidance “Information for Manufacturers 

Seeking Marketing Clearance of Diagnostic Ultrasound Systems and 

Transducers” 

o Describes the types of modifications to a diagnostic ultrasound device 

for which FDA does not intend to enforce the requirement for a new 

premarket notification (510(k)) -- the 2008 guidance had specified a new 

510(k) for these types of modifications 

o Includes a new transducer element check that applies to all ultrasound 

devices covered in this guidance

Final Guidance Scope
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• The FDA does not intend to enforce compliance with the 510(k) requirement for certain 

modified ultrasound and transducer devices (that have already obtained an initial 510(k) 

clearance) when the following apply:

o The intended use of the modified device is not changed

o The device is not a reusable device subject to the requirement for the submission of 

reprocessing labeling and validation data

o The modes of operation for the modified device are well-established

o The modifications do not lead to acoustic outputs that exceed the recommended maximum 

acoustic output levels

o The modifications do not result in a range of ultrasound interrogation parameters outside a 

well-known range, specified in the guidance document

Compliance Policy
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• The FDA does not intend to enforce compliance with the 510(k) requirement for certain 

modified ultrasound and transducer devices (that have already obtained an initial 510(k) 

clearance) when the following apply:

o The modifications do not utilize novel mechanical or thermal effects for imaging or 

measurements

o The measurements and analyses are clearly described and the user can adjust the 

associated control parameters

o Transducer element check is performed

o Transducer surface temperature falls within a well-defined range, and

o Appropriate transducer covers are recommended to users 

Compliance Policy (Continued)
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o Integrated tests of transducer performance each time a transducer is connected 

to the main system or activated

o The transducer performance test should be accessible by competent technical 

personnel, such as operators or service personnel

o While the FDA appreciates that different performance specifications may be 

necessary for transducers based on the application and system configuration, 

each device should include some level of testing. For example, an impedance 

check of each transducer element may provide a preliminary evaluation of the 

element integrity and function.

Transducer Element Check
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o Device manufacturers implement methods to communicate the results of the 

transducer performance tests to the operators, and identify regions of the image 

that have been compromised by transducer malfunction

o This integrated test feature would also generate a report on the performance of 

the probe under test for documentation, generally including a list of elements or 

smallest available patches of elements that have been compromised

o This integrated test should also be available to the operators to initiate any time 

when a particular probe is suspected of failure

Transducer Element Check (Continued) 
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o Output Display Standard: IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular 

requirements for the basic safety and essential performance of ultrasonic medical diagnostic and 

monitoring equipment, 2015

o IEC 62359 Ultrasonics - Field characterization - Test methods for the determination of thermal and 

mechanical indices related to medical diagnostic ultrasonic fields, 2017 

o IEC 62127-1 Ultrasonics -- Hydrophones -- Part 1: Measurement and characterization of medical 

ultrasonic fields up to 40 MHz., 2013 

o IEC 62127-1 Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz, 

Annex I, 2013 

o ES60601-1 Medical electrical equipment—Part 1: General requirements for basic safety and 

essential performance, 2005/(R)2012 and A1:2012 

o IEC 60601-1-2 Medical electrical equipment—Part 1-2: General requirements for basic safety and 

essential performance –Collateral standard: Electromagnetic disturbances –Requirements and tests, 

2014

o Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 

Devices, dated September 14, 2018

Updated Consensus Standards
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• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 

Devices, dated September 14, 2018: https://www.fda.gov/media/71983/download

• Deciding When to Submit a 510(k) for a Software Change to an Existing Device, dated October 

25, 2017: https://www.fda.gov/media/99785/download

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 

Program, dated May 7, 2019: https://www.fda.gov/media/114034/download

• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, dated 

March 17, 2015: https://www.fda.gov/media/80265/download

• Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered 

Medical Devices, dated July 11, 2016: https://www.fda.gov/media/94758/download

• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions 

for Devices Labeled as Sterile, dated January 21, 2016: 

https://www.fda.gov/media/74445/download

• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, dated 

October 2014: https://www.fda.gov/media/86174/download

Updated Guidance Documents
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Compliance Policy:

The revised final guidance enables manufacturers with an established track record of 

ultrasound device development, via submission of 510(k)s for their original devices, to add 

new safety features and make certain modifications to address clinical needs without the need 

to submit another 510(k). 

Key Take-Aways
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o The new transducer element check provides a mechanism for users to test possible 

degradation due to aging and ensure continued safety and effectiveness 

o Reduce review of modifications with established history of safety and effectiveness 

o Transition Period: The guidance is effective immediately. Please note that guidance 

documents represent FDA’s recommendation. Manufacturers should address the 

recommendations.

o There will be presentations at professional societies

Key Take-Aways (Continued)
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o Adding Continuous-Wave (CW) and Pulsed-Wave (PW) Doppler interrogation methods 

to the modes of operation of the device. 

o Adding an algorithm that measures the volume of an organ based on scientifically well- established image segmentation and volume calculation methods. The scientific basis 

of the algorithm should be disclosed to the users for optimal usage of the measurement.

o Adding a new transducer with similar indications for use and similar acoustic output as 

one already cleared in the system. The new transducer may have a new clinical 

application, if the particular clinical application (e.g., indication) has been cleared for 

another transducer, manufactured by the same manufacturer. 

o Adding a B-mode noise reduction filter for general imaging use to a system. The 

characteristics of the algorithm used for the noise reduction are defined.

Examples of Compliance Policy Applications
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o“Marketing Clearance of Diagnostic Ultrasound Systems and 

Transducers, Guidance for Industry and Food and Drug 

Administration Staff,” dated June 27, 2019:

https://www.fda.gov/media/71100/download

Resources
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Questions?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

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