Do you need a prescription for dilators?
The FDA requires vaginal dilators to be cleared for either prescription use (Rx) or over-the-counter (OTC) use. There's no FDA-compliant path for selling vaginal dilators without prescription or OTC clearance.
Intimate Rose is proud to be one of only TWO companies with full FDA approval to offer vaginal dilators in both RX and OTC settings. This challenging yet important milestone highlights our commitment to patient safety, well-being, and the following of federal regulations, no matter the cost.
Because of this OTC clearance, there is no prescription requirement to access Intimate Rose Vaginal Dilators.
Why does FDA Clearance Matter?
FDA clearance ensures that a product has passed rigorous safety testing and meets strict federal standards. For medical devices like vaginal dilators, this means the product is safe and effective.
Without FDA clearance, there's no guarantee of safety. At Intimate Rose, we've gone through the difficult FDA clearance process because we prioritize safety and reliability, as well as simply following the rules.
FAQs
Where can I find official FDA documentation?
Here is a link to the FDA document on Vaginal Dilators: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=HDX.
This link shows that Vaginal Dilators are considered a class 2 medical device that require 510(k) clearance and approval to be compliant with the FDA.
Does this apply to all vaginal dilators or just Intimate Rose?
The FDA Documentation is clear, vaginal dilators are subject to Class 2 / 510(k) clearance to be sold in the USA. This clearance comes with two statuses: RX only and over-the-counter (OTC). Intimate Rose is proud to be one of ONLY two companies to have received OTC designation for vaginal dilators.
Does this have something to do with insurance or FSA?
No, this is completely independent of any insurance or FSA compliance, and that isn't a cause or effect of this.