The rational of removing the Rx on filters for CPAP machines is correct?
The Food and Drug Administration (FDA) classifies CPAP devices as Class II medical devices with possible risks. Therefore, their sale requires a medical prescription. The use of these medical products is not safe except when used under the supervision of a medical practitioner licensed by law to oversee their use.
Federal law requires that CPap and BiPap machines and portable oxygen concentrators be purchased only with a prescription issued by a licensed medical practitioner.
CPAP Accessories including filters and mask assembly kits are the only pieces of equipment sold without a prescription.
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Elizabeth Lucado
Chula Vista CA
United States
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