How long does FDA 510(k) clearance take for a menstrual cup?

The FDA standard review timeline for 510(k) submissions is 90 days from acceptance. However, the preparation phase — including biocompatibility testing, clinical data, and technical file assembly — typically adds 6–12 months before submission.

Can I sell menstrual cups in the EU under my own brand using my OEM manufacturer's CE marking?

No. CE marking is product and manufacturer-specific. If you are selling under your own brand name, you need your own CE marking for your specific private label product. Your OEM factory's CE certificate covers their branded product, not yours.

Menstrual Cup FDA & CE Certification Guide for Brands

Q: Do menstrual cups require FDA approval to sell in the US?

Yes. Menstrual cups are classified as Class II medical devices in the US and require FDA 510(k) clearance before commercial sale. The manufacturer's facility must also be registered with the FDA and follow 21 CFR Part 820 quality system regulations.

Q: What is the cost of FDA 510(k) clearance for a menstrual cup?

FDA 510(k) application fees for small businesses are approximately $6,000–$8,000. Regulatory consultants typically charge $10,000–$30,000 for submission preparation. Total cost including testing and preparation is usually $20,000–$50,000 depending on the complexity of the submission.

Menstrual cups are regulated as medical devices in both the US and European Union — which means private label brands cannot simply manufacture and sell them without regulatory approval. This is the most common point of confusion for first-time buyers entering the category.

The good news: the process is manageable, and a factory with existing regulatory experience can dramatically reduce your cost and timeline. Here is everything you need to know.

US Market: FDA 510(k) Clearance

In the United States, menstrual cups are classified as Class II medical devices under 21 CFR 884.5900. To sell a menstrual cup commercially in the US under your brand, you must obtain FDA 510(k) clearance — which establishes that your product is “substantially equivalent” to a legally marketed predicate device.

What You Need for a 510(k) Submission

Device description: Full technical specifications of your menstrual cup (dimensions, materials, silicone grade, Shore hardness, capacity)
Predicate device comparison: Identification of an FDA-cleared menstrual cup you are substantially equivalent to
ISO 10993 biocompatibility data: Full test reports for cytotoxicity, sensitization, and systemic toxicity
Performance testing: Leakage testing, insertion/removal force data, capacity data
Labeling: Draft labeling compliant with 21 CFR 801 requirements
Manufacturing information: FDA-registered facility details

Phase	Duration	Key Actions
1. Testing	3–6 months	ISO 10993 biocompatibility, performance testing
2. Technical file	2–3 months	Technical documentation, labeling, predicate comparison
3. FDA review	90 days	FDA standard review; may issue additional questions
Total timeline	9–18 months	From project start to clearance

EU Market: CE Marking Under MDR 2017/745

In the European Union, menstrual cups are classified as Class IIa medical devices under the Medical Device Regulation (MDR) 2017/745. CE marking is mandatory for sale in any EU member state, as well as in the UK (UKCA marking), Norway, Iceland, and Switzerland.

CE Marking Requirements for Menstrual Cups

Notified Body involvement: Class IIa devices require conformity assessment by an EU Notified Body (e.g., BSI, TÜV SÜD, SGS)
Technical documentation: Device description, risk management file (ISO 14971), clinical evaluation report, performance data
EU Authorized Representative: Non-EU manufacturers must appoint an EU-based AR
Eudamed registration: Device and economic operator registration in the EU database
Post-market surveillance: Ongoing vigilance and reporting obligations

⚠️ Important: CE marking is brand and product-specific. Your OEM factory’s CE certificate covers their product under their name. If you are selling under your own private label brand, you must obtain CE marking for your specific product configuration. Your factory can provide the technical documentation to support your submission, but the application must be made in your company’s name.

How Your OEM Factory Can Help

The right manufacturing partner can significantly reduce the cost and complexity of your regulatory submission. Here is what to expect from a factory with medical device experience:

Existing test reports: ISO 10993 biocompatibility data for their silicone formulation (reduces your testing cost if you use their standard material)
Technical file templates: Pre-built device description documents, material spec sheets, and risk management frameworks
FDA-registered facility: Eliminates the need for you to register a separate manufacturing location
ISO 13485 quality system: Required by both FDA and EU MDR; the factory’s certification covers your product
Referrals to regulatory consultants: Experienced factories maintain relationships with consultants specializing in FDA and CE submissions for this product category

Frequently Asked Questions

Do menstrual cups require FDA approval to sell in the US?

Yes. Menstrual cups are Class II medical devices requiring FDA 510(k) clearance. The manufacturing facility must also be FDA-registered and comply with 21 CFR Part 820 quality system regulations.

What is the cost of FDA 510(k) clearance for a menstrual cup?

FDA application fees for small businesses are approximately $6,000–$8,000. Regulatory consultant fees for submission preparation typically range from $10,000–$30,000. Total cost including biocompatibility testing is usually $20,000–$50,000.

How long does FDA 510(k) clearance take?

The FDA standard review is 90 days from acceptance. The preparation phase — biocompatibility testing, clinical data, and technical file — typically takes 6–12 months before submission. Total timeline from project start to clearance is usually 9–18 months.

Can I sell in the EU under my own brand using my OEM manufacturer’s CE marking?

No. CE marking is product and manufacturer-specific. If you sell under your own brand name, you need your own CE marking for your private label product. Your factory’s CE certificate covers their branded product. Your factory can provide supporting technical documentation, but the CE application must be in your company’s name.

About the manufacturer

TamponManufacturer.com manufactures menstrual cups from 100% medical-grade platinum-cured silicone. ISO 10993 certified, FDA-registered facility, ISO 9001 certified. We provide full technical documentation to support your FDA 510(k) and CE marking submissions. MOQ from 1,000 units.

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Menstrual Cup FDA & CE Certification: A Step-by-Step Guide for Private Label Brands