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Evaluation of the Feasibility, Safety, and Accuracy of an Intraoperative High-intensity Focused Ultrasound Device for Treating Liver Metastases

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Device Safety.

Vinay K Rathi¹, Stacey T Gray¹

¹Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, 243 Charles Street, Boston, MA 02114, USA; Department of Otolaryngology, Harvard Medical School, Boston, MA, USA.

Otolaryngologic Clinics of North America

|September 25, 2018

Summary

This summary is machine-generated.

The US Food and Drug Administration (FDA) regulates medical devices for otolaryngology. Understanding FDA device regulation, premarket standards, and postmarket surveillance helps doctors counsel patients on risks and benefits.

Keywords:

510(k)FDA Medical device Otolaryngology Postmarket studies Premarket approval

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Area of Science:

Otolaryngology
Medical Device Regulation
Public Health

Background:

Medical devices are crucial for diagnosing and treating ear, nose, and throat diseases.
The US Food and Drug Administration (FDA) ensures the safety and effectiveness of medical devices.
Otolaryngologists play a key role in informing patients about device-related risks and benefits.

Purpose of the Study:

To review the FDA's regulatory framework for medical devices.
To explain premarket evidentiary standards for device approval.
To outline postmarket safety surveillance methods.

Main Methods:

Review of FDA regulations and guidelines.
Analysis of premarket approval processes.
Examination of postmarket surveillance systems.

Main Results:

The FDA employs a multi-faceted regulatory approach for medical devices.
Premarket review requires specific evidence of safety and effectiveness.
Postmarket surveillance continuously monitors device performance and safety.

Conclusions:

Awareness of FDA medical device regulation is vital for otolaryngologists.
Understanding regulatory strengths and limitations enhances patient counseling.
Informed physicians can better guide patients in device-based treatment decisions.