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This page describes products and general use; it is not medical advice.
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A menstrual cup is a receptacle worn internally, and the material it is made of is the first thing FDA asks a manufacturer to justify. In FDA’s October 2025 draft guidance, silicone is the example of a material with a well-established safety profile for menstrual cups. Neither the federal regulation nor the guidance lists a required material. This page explains what that means, how FDA expects cup materials to be documented, and how to read a cup’s component label. It is written for clinic staff, buyers and students who need to understand the product class.
What a menstrual cup is
Under 21 CFR 884.5400, a menstrual cup is “a receptacle placed in the vagina to collect menstrual flow.” It is a Class II device (special controls) that is exempt from premarket notification (510(k)) under subpart E of part 807, subject to the limitations in 21 CFR 884.9. FDA’s product code for the device is HHE. The regulation names no material. For how a cup differs from a disc, see menstrual cup vs disc.
Who uses it: consumers buy menstrual products over the counter; clinic staff, buyers and students meet the product class when comparing labeling or answering material questions.
How a cup is built: materials and components
FDA’s draft guidance “Menstrual Products – Performance Testing and Labeling Recommendations” (October 2025) covers tampons, pads and menstrual cups. Unlike tampons and pads, a cup does not absorb fluid: the guidance states that absorbency range does not apply to menstrual cups. What matters for a cup is therefore the patient-contacting material and any coating, applicator or other component.
The guidance includes a sample ingredient table for a cup, shown below. These rows are FDA’s example of the labeling format, not a survey of products on the market.
| Component in FDA’s example | Material listed | Function given by FDA |
|---|---|---|
| Menstrual cup | Silicone | Primary material of the cup |
| Menstrual cup | Parylene C | Lubricant coating |
| Applicator (if the product has one) | TPU (Pellethane) tip, nylon barrel, colorant | Helps insert the cup; tip and barrel are the primary materials of the applicator |
| Pusher | Polypropylene | Used to make the pusher base; helps in deployment |
Source for the table: FDA draft guidance, Table 5b, checked 2026-10-30. For background on thermoplastic materials used in medical products, see what is a thermoplastic elastomer and TPE vs TPU.
How FDA looks at cup materials
Biocompatibility is required for every patient-contacting material
FDA states that pads and menstrual cups contain patient-contacting materials which, used as intended, may induce a harmful biological response. A manufacturer should determine the biocompatibility of all patient-contacting component materials. The guidance treats these products as surface devices in contact with mucosal membrane for a long-term contact duration, because although each use is under 24 hours, lifetime use can exceed 30 days of cumulative exposure.
Silicone as the benchmark, and when it is not enough
If a cup is made of materials with well-established safety profiles consistent with previously cleared or marketed devices, FDA gives “silicone for menstrual cups” as its example. In that case a subset of the listed biocompatibility testing may be sufficient, and the manufacturer should list the component materials, including additives, and explain why their safety is well established, including prior use in devices of the same type. If a cup contains novel materials or materials with known biocompatibility risk, the abbreviated list of testing may not be sufficient. An applicator is tested separately from the cup.
For the wider framework, see FDA guidance on biocompatibility and FDA device classification, 510(k) and PMA.
Materials, use instructions and toxic shock syndrome risk
Because a cup is indwelling, FDA recommends that the manufacturer assess toxic shock syndrome (TSS) risk based on the instructions for use (for example dwell time, reprocessing and use life) and the materials of construction. The risk analysis should consider design, material biocompatibility and chemical safety, physical impact on the vaginal mucosa, and impact on vaginal microbiota. This is a manufacturer’s design obligation described in a draft guidance; it does not tell a user what is safe for an individual.
Reading a cup’s ingredient label
FDA recommends that the outer package label identify each ingredient or component of a menstrual product. For a cup, the guidance asks that each component be listed separately (cup, applicator, pusher), with materials in order of percent of the component, highest to lowest, and a short statement of each one’s purpose. Where animal or plant-derived materials are used, the species or source should be named. For a related product class, see tampon ingredients.
Cleaning, reuse and what the instructions for use control
FDA recommends documentation supporting any performance characteristic stated in the labeling, such as washability or useable life, and says reprocessing validation testing (cleaning and/or disinfection) should be documented to support that the labeling is adequate. The directions for use are expected to cover how the product is used and worn, wear time, reuse if applicable, disposal, whether it is single or multiple use, and intended users. The cleaning and replacement instructions for a specific cup are therefore the manufacturer’s, and the package insert is the source to follow. Size selection information and the volume a cup holds for its stated duration of use belong in the device description.
Common mistakes
- Assuming the regulation requires silicone. 21 CFR 884.5400 identifies the device and its class and names no material.
- Treating FDA’s sample table as a market survey. It illustrates the labeling format.
- Treating a draft guidance as a binding rule. FDA states the guidance is nonbinding and that an alternative approach may be used if it satisfies the statutes and regulations.
- Comparing materials while ignoring coatings, applicators and additives, which FDA asks to be listed as separate components.
- Reading a material name as a safety verdict. FDA frames safety as evidence the manufacturer documents, not as a property of a material name.
FAQ
Are menstrual cups made of silicone?
Silicone is the material FDA names as its example of a well-established material for menstrual cups, and it is the primary cup material in FDA’s sample ingredient table. The regulation itself does not require it, so the component label of a specific product is the authority for that product.
Does FDA clear menstrual cups before sale?
Menstrual cups (product code HHE) are Class II and exempt from 510(k) premarket notification, subject to the limitations in 21 CFR 884.9. Exempt does not mean unregulated: they remain Class II devices with special controls.
What testing does FDA recommend for cup materials?
Biocompatibility evaluation of all patient-contacting materials, a possibly abbreviated set of tests for materials with well-established safety profiles such as silicone, more for novel materials, separate testing of any applicator, TSS risk assessment, and reprocessing validation to support cleaning instructions.
Sources
- U.S. FDA, draft guidance “Menstrual Products – Performance Testing and Labeling Recommendations,” October 2025, fda.gov/media/189362/download. Checked 2026-10-30.
- 21 CFR 884.5400, Menstrual cup, law.cornell.edu/cfr/text/21/884.5400. Checked 2026-10-30.
