FDA Classifies Computerized Fibromyalgia Therapy Device as Class II
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The Food and Drug Administration has officially classified a computerized behavioral therapy device for treating fibromyalgia symptoms into Class II. This classification means the agency believes special controls, combined with standard safety rules, are enough to ensure the device is safe and effective.
Why it matters: This action lowers the barrier for companies to sell this type of therapy tool by moving it out of the most restrictive regulatory category. It allows manufacturers to use a simpler notification process called 510(k) to get their versions approved, rather than undergoing the more expensive and time-consuming premarket approval required for Class III devices.
Who it affects
- Manufacturers of computerized behavioral therapy devices for fibromyalgia
This final order was issued by the FDA and published in the Federal Register; readers should consult the original document for the full list of special controls.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document