Direct comparison
Menstrual Cup vs Disc: FDA Class and Labeling
Menstrual cup vs disc: both sit under FDA product code HHE, but 21 CFR 884.5400 and the 2025 draft guidance name only cups. What to check on any label.
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How do Menstrual cup, Menstrual disc compare side by side?
The table below compares Menstrual cup, Menstrual disc across 12 procurement-relevant dimensions, from definition in 21 cfr 884.5400 through when to use which document.
Side-by-side comparison
| Dimension | Menstrual cup | Menstrual disc |
|---|---|---|
| Definition in 21 CFR 884.5400 | "A menstrual cup is a receptacle placed in the vagina to collect menstrual flow." | The regulation defines only a "menstrual cup"; it has no separate definition for a disc. |
| FDA product code | HHE (menstrual cup). | HHE. An FDA MAUDE device report lists a disposable menstrual disc under product code HHE. |
| Device class and premarket status | Class II, exempt from 510(k) subject to the limitations in 21 CFR 884.9. Exempt is not the same as FDA-approved. | FDA documents show no separate classification for discs; the HHE code and 21 CFR 884.5400 are the entries found. |
| Named in FDA's October 2025 draft guidance | Yes. The guidance covers "tampons, pads, and menstrual cups" (draft, nonbinding). | Not named in the guidance scope. |
| Absorb or collect (FDA guidance) | Collects. The guidance says absorbency range does not apply to menstrual cups, which do not absorb fluid. | Not addressed in the guidance. |
| Capacity labeling | FDA recommends stating the volume of menstrual fluid the cup can hold for the stated duration of use. | The cup recommendation is not written for discs; read the product label for any stated capacity. |
| Materials and ingredient labeling | Silicone is cited as a material with a well-established safety profile. Components (cup, applicator, pusher) should be listed separately on the outer package. | The guidance does not address disc materials; read the material and component list on the product's own label. |
| Biocompatibility category | Surface device in contact with mucosal membrane, long-term contact (cumulative use over 30 days, each use under 24 hours). | Not addressed in the guidance for discs. |
| Toxic shock syndrome (TSS) | FDA: because cups are indwelling in the vagina there is a potential TSS risk, assessed from dwell time, reprocessing, use life and materials in the instructions for use. | The guidance does not name discs. The product's instructions for use govern wear time and warnings. |
| Cleaning and reuse | For reusable cups FDA recommends validation testing of cleaning and/or disinfection that supports the labeling and the stated useable life. | Follow the instructions for use of the specific product, including whether it is single-use or reusable. |
| Source | FDA, "Menstrual Products - Performance Testing and Labeling Recommendations", draft guidance, October 2025 (fda.gov/media/189362/download); 21 CFR 884.5400 (law.cornell.edu/cfr/text/21/884.5400); FDA Product Classification, code HHE. Read 2026-10-30. | FDA MAUDE report mdrfoi 17841172 (product code HHE, "disposable menstrual disc"), accessdata.fda.gov. A single device report, not an FDA finding. Read 2026-10-30. |
| When to use which document | Use the cup's instructions for use for wear time and cleaning; FDA's draft guidance describes the labeling items it recommends for cups. | Use the disc's own instructions for use for the same items. Questions about personal fit or symptoms belong with a clinician. |
Common questions
Common questions about Menstrual cup vs Menstrual disc
What is the difference between a menstrual disc and a cup?
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In FDA documents the regulation (21 CFR 884.5400) defines a menstrual cup as a receptacle placed in the vagina to collect menstrual flow, and FDA's October 2025 draft guidance covers cups. A disposable menstrual disc appears in an FDA device report under the same product code, HHE. Product-level differences are set out in each product's instructions for use.
What is a menstrual disc?
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FDA's regulation text defines only the menstrual cup. A device report in FDA's MAUDE database lists a "disposable menstrual disc" under product code HHE. For what a specific disc is made of and how it is used, read that product's label and instructions for use.
Is a menstrual disc a cup under FDA rules?
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FDA documents do not say so. Both appear under product code HHE, but 21 CFR 884.5400 and the 2025 draft guidance use the term menstrual cup, and no separate classification for discs was found. The guidance is draft and nonbinding.
Does FDA approve menstrual cups?
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The classification is Class II and exempt from 510(k) premarket notification, subject to the limitations in 21 CFR 884.9. That is an exemption from premarket notification, not an FDA approval.
Going deeper
