FDA Needle Reclassification
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Companies that sell needles for general use will be required to obtain government clearance, prove that they are well-manufactured and label them "for single use only," according to the FDA.
The change from Class 3 to Class 2 means the needles no longer require clinical studies to prove they are safe and effective.
By reclassifying the needles, the FDA removed an obstacle to insurance coverage for acupuncture treatments. Because of its experimental status, many insurance companies and government insurance programs refused to cover the treatment.
Acupuncture.com |