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  5. Medical Acoustics Program: Research on Medical Acoustic Devices
  1. Medical Device Regulatory Science Research Programs Conducted by OSEL

Medical Acoustics Program: Research on Medical Acoustic Devices

The Medical Acoustics Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patients have access to innovative medical acoustic devices that are safe and effective. The Medical Acoustics Program currently encompasses two sub-programs across acoustic and ultrasound devices: Therapeutic and Diagnostic sub-program and Transcranial sub-program. This is one of the active research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Scope of Medical Acoustic Devices

Medical acoustic devices (commonly referred to as medical ultrasound) emit sound waves through a targeted area of the body for therapeutic or diagnostic purposes. This includes devices that operate at frequencies above 20 kHz such as shear wave imaging, physiotherapy, lithotripsy, histotripsy and high intensity therapeutic ultrasound (thermal ablation) as well devices that operate at 10 Hz – 20 kHz such as digital stethoscopes. Devices used for transcranial ultrasound/acoustic applications intend to target areas within the brain for a desired effect, such as opening of the blood-brain barrier, ablation using thermal and/or mechanical techniques, and neuromodulation.

The FDA receives numerous medical device submissions covering a wide range of clinical applications for the entire spectrum of patients (pediatrics to geriatrics) and during perinatal stages. Some examples include:

  • Brain diseases (essential tremor, drug delivery, Alzheimer’s)
  • Treatment of tumors (non-invasive thermal ablation of cancerous tumors)
  • Mental health (opioid addiction, depression)
  • Pain management (thermal stimulation for joint pain, nerve stimulation for pain relief)
  • Cardiovascular applications (vessel occlusion, diagnosis of cardiovascular disease)
  • Women’s health (uterine fibroid removal)
  • Pediatric (rare diseases, tumor ablation)
  • Cosmetic applications (ultrasound facelift, varicose veins)
  • Wearable applications (ultrasound patch)
  • Ophthalmological (glaucoma)

However, multiple gaps remain between the clinical use of medical acoustic devices and the development and characterization of the testing needed to assess clinical safety. Appropriate testing methods that span across these clinical applications are needed to stimulate innovation and safe adoption of this technology.

Regulatory Science Gaps and Challenges

Major regulatory science gaps and challenges that drive the Medical Acoustics Program are:

  • Lack of preclinical and clinical understanding of transcranial ultrasound/acoustic devices and applications.
  • Lack of standardized acoustic and thermal characterization methods that would increase efficiency in demonstrating safety and effectiveness.
  • Lack of standardized computational models of acoustic and thermal fields that would demonstrate safety and effectiveness.
  • Need for product development and patient access to therapeutic and diagnostic ultrasound/acoustic devices across all populations.

The Medical Acoustics Program aims to fill these knowledge gaps by fostering the development of regulatory science tools that help manufacturers assess the safety and performance of their devices. This work also makes the FDA better prepared for addressing technical issues that may be related to the performance of these devices at both the premarket and postmarket stages in the medical device lifecycle.

Medical Acoustics Program Activities

The Medical Acoustics Program focuses on regulatory science research in these areas:

  • Investigation of the short-term and long-term safety and effectiveness of transcranial ultrasound/acoustic devices and applications.
  • Development of standardized acoustic and thermal characterization methodologies and tools, including computational approaches, for therapeutic and diagnostic devices.
  • Development of tools that will be the basis for and drive standards and guidelines for therapeutic and diagnostic devices.
  • Development of tools that will address safety and effectiveness requirements for targeted populations (e.g., pediatrics, high risk patients) or emerging technologies treated with therapeutic and diagnostic devices.

For more information, email OSEL_MedicalAcoustics@fda.hhs.gov

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