Do you need a prescription for dilators?

Yes, vaginal dilators require a prescription per the FDA guidelines. The FDA has classified vaginal dilators as class two medical devices, which means companies selling vaginal dilators need to submit a 510(K) document to demonstrate their safety and effectiveness.

Intimate Rose has been working with the FDA for years, already has the 510(K) and is in the process of obtaining over-the-counter (OTC) designation for their vaginal dilators. This will allow Intimate Rose vaginal dilators to be sold without a prescription. However, until that designation is completed, we are adhering to the FDA’s guidance and not selling dilators without prescriptions to individual customers.

In the meantime, patients can still access Intimate Rose dilators through safe and compliant means. Intimate Rose is arranging prescriptions for customers at no additional charge.

For more information, please see our video updates below and FAQs.



Prescriptions for Patients: Aaron's Update 3/14/24

Please visit our dedicated page on prescription status by state as informed by our thorough investigation.


An Update From Aaron 2/25/24



Amanda and Aaron Share Overview of FDA Regulation on Vaginal Dilators 2/22/24



How do my patients give their script to Intimate Rose?

We've added the ability to upload a script as part of the purchase process. Visitors on can choose the Prescription Upload link directly below the Add To Cart button on dilator product pages. Visitors can upload their script via mobile or desktop. Any file version will work, including a picture of the script. Alternatively, visitors can email a copy of their script to

What is the longer term plan?

Clinicians have three options for providing scripts:

  1. Provide your patient with a script, which the patient can use to upload a picture or PDF file at checkout.  If you're an NP or MD, in most states you have prescriptive rights yourself.  If you're a PT or OT, you can go to our state tracking page to check the guidelines for your state to see if you can write the script yourself, or if you'd need to coordinate with another provider.
  2. Submit script directly to IR using our online Script Pad. The patient will be able to complete their order without requirement for uploading a script.
  3. If you are not able to provide a script, we have NPs and MDs available to provide one for your patient. There is no cost or action required by you. Intimate Rose will connect the patient with an NP or MD for a prescription before the order will be shipped.

What can I do as a healthcare provider?

As an NP or MD, generally, you can write the prescription yourself.

Check our State Tracking page to see if PTs and OTs can write scripts in your state. If so, provide your patient with a script to simplify the checkout process. Patients can upload the script as part of checkout and their order will be delivered.

Alternatively you can submit a script through our online Script Pad. Patients will be able to complete their order without the need to upload a script.

If it is unclear if PTs / OTs in your state can write a script, reach out to your state board and ask. Let us know what you find out so we can update the State Tracker if we haven't already.

If your state does not allow PTs / OTs to write scripts, you can also partner with a local NP or MD for script referrals.

Where can I find official FDA documentation?

Here is a link to the FDA document on Vaginal Dilators:

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 OTC.  Intimate Rose achieved the first step, which is to be FDA Cleared for RX only.  We’ve almost completed the next step to acquire OTC status.  Companies who do not have either of these clearances which are selling vaginal dilators are breaking FDA regulations, even if they list under an incorrect category or product code.  Based on our discussions with the FDA, lawyers, and consultants, we are taking the best approach for patients, clinicians, and government regulators.

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.

How is Intimate Rose able to get scripts for patients?

A group of NPs and MDs, with prescriptive rights, have rallied behind us to support the cause for pelvic health.  If your patient does not upload a script during checkout, we will collect some basic information from them and connect them with an NP or MD if one is available for their state. We do not have all states covered yet, but are adding states to the list weekly! The provider will contact the patient if additional information is needed depending on state requirements. There is no cost to the patient or you for this service.