FDA classifies oropharyngeal electrical stimulator as Class II device

The Food and Drug Administration has officially classified a type of medical device called an oropharyngeal electrical stimulator into Class II. This classification means the agency believes special controls, combined with standard regulations, are enough to ensure the device is safe and effective for its intended use.

Why it matters: This action removes the automatic Class III designation that applied to new devices not previously on the market before 1976. Class III usually requires a more burdensome premarket approval process. Moving this device to Class II allows manufacturers to use a simpler notification process for future similar products, which could speed up access to these treatments for patients with swallowing disorders.

Who it affects

• Manufacturers of oropharyngeal electrical stimulators and related medical devices

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This summary is based on a final order published by the Food and Drug Administration in the Federal Register; readers should consult the original document for full regulatory text and specific compliance requirements.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document