U.S. Food and Drug Administration
Tampons are medical devices regulated by the U.S. Food and Drug Administration. If you or a loved one uses them, it's important to use them safely. Learn the basics. Apr 16, · Understand that using tampons doesn't make you lose your virginity. Contrary to one particularly unhelpful myth, using tampons does not make you "lose your virginity." Tampons might stretch the hymen (the thin membrane that usually stretches when you have sex), but the hymen should not tear. The hymen only partially covers the vaginal opening and is intended to stretch and bend.
New Delhi : Menstruation is normal and a healthy part of life and yet girls and women in India go through extreme struggles to manage their period every month. When a girl faces challenges in managing her period in a healthy manner, it can cause senior women how to make the extra money you need number of problems to her physical as well as mental health.
Not only will she be at risk of infection, but her education, self-esteem, and confidence also suffer in a major way. National Family Health Survey estimates that of the million menstruating women in India about million roughly 36 percent women are using sanitary napkins, locally or commercially produced. Also Read: Period. Most common menstrual hygiene product in India is sanitary napkin which is disposable and they can have an adverse impact on the environment due to the huge amounts of plastics they contain.
Conventional sanitary pads and tampons available in the market are loaded with plastic. These menstrual products are used for at least days per month by most women worldwide. This means a huge amount of plastic waste is generated every month globally. After being disposed of, sanitary products that are usually made out of plastic take over years to break down. The alternatives to sanitary napkins could be menstrual cups, tampons and eco-friendly sanitary pads.
We often hear that unhygienic period health and disposal practices can have major consequences on the health of women, but what exactly is at risk here? Every person — male or female should be aware of the diseases that could be caused if a woman does not have access to menstrual hygiene products.
The study further explains how many girls even think that they are dying or have caught a horrible disease, the first time they menstruate, due to the pain and blood. Helmed by Campaign Ambassador Amitabh Bachchanthe campaign aims to spread awareness about hygiene and sanitationthe importance of building toilets and making India open defecation free ODF by Octobera target set by Prime Minister Narendra Modiwhen he launched Swachh Bharat Abhiyan in Over the years, the campaign has widened its scope to cover issues like air pollutionwaste managementplastic banmanual scavenging and menstrual hygiene.
Your email address will not be published. Langar Sewa At The Doorstep? Research Reveals. Thank You Donors. Menstrual Hygiene. May 28 is observed as Menstrual Hygiene Day globally. Leave a Reply. You may also like. Highlights: SwasthyaMantra Telethon. All rights reserved.
Aug 27, · There’s one big reason for this: tampons are incredibly rare in China– only 2% of Chinese women use them; in Europe, the figure is as high . If you use a tampon, but have never had sex, you are still a virgin. So why do people ask this question? Girls who are virgins usually have a hymen, a very thin piece of skin-like tissue that partly covers the opening of the vagina. Options Key: colorable Work muchs like brushes - you pick the stamp to get the shape, and then pick the color you want it to be. Nothing about the original image is used except the transparency (from "alpha" channel). The color of the stamp comes out solid.
For questions regarding this document contact Colin Pollard, at , or by email at colin. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional copies are available from the Internet. Please use the document number to identify the guidance you are requesting. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
FDA has developed this guidance document to assist industry in preparing premarket notification submissions k for menstrual tampons and pads that are subject to k requirements. This guidance covers the key recommendations for the content of k submissions for these devices. Depending on any unique design, technology, indications, and performance characteristics of a given product, FDA may recommend additional information not described in this guidance.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
The Least Burdensome Approach The issues identified in this guidance document represent those that we believe should be addressed before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making.
We also considered the burden that may be incurred in your attempt to follow the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. A manufacturer who intends to market a device of the generic types subject to this guidance should conform to the general controls of the Federal Food, Drug, and Cosmetic Act the Act , including the premarket notification requirements described in 21 CFR Subpart E, and obtain a substantial equivalence determination from FDA prior to marketing the device.
This guidance document identifies the classification regulations and product codes for menstrual tampons and pads Refer to Section 4. In addition, other sections of this guidance document list the risks to health identified by FDA and describe measures that will generally address the risks associated with these menstrual tampons and pads and lead to a timely review and clearance.
This document supplements other agency documents regarding the content requirements of a k. FDA believes an Abbreviated k provides the least burdensome means of demonstrating substantial equivalence for a new device, particularly once FDA has issued a device-specific guidance document. Manufacturers considering modifications to their own cleared devices may lessen the regulatory burden by submitting a Special k.
An Abbreviated k submission must include the required elements identified in 21 CFR In an Abbreviated k , FDA may consider the contents of a summary report to be appropriate supporting data within the meaning of 21 CFR The report should describe how this guidance document was used during the device development and testing and should briefly describe the methods or tests used and a summary of the test data or description of the acceptance criteria applied to address the risks identified in this document, as well as any additional risks specific to your device.
This section suggests information to fulfill some of the requirements of Coversheet The coversheet should prominently identify the submission as an Abbreviated k and cite the title of this guidance document.
Proposed labeling Proposed labeling should be sufficient to describe the device, its intended use, and the directions for its use. Please refer to Section Labeling for specific information that should be included in the labeling for devices of the types covered by this guidance document.
Description of the device and its intended use We recommend that the description include a complete discussion of the performance specifications and, when appropriate, detailed, labeled drawings of the device. Please refer to section 5. Device Description for specific information that we recommend you include in the device description for devices of the types covered by this guidance document.
Description of device design We recommend that you include a brief description of the device design requirements. You should also include the results of this analysis. Please refer to Section 6. Risks to Health for the risks to health identified by FDA that are generally associated with the use of this device. Discussion of the device characteristics We recommend that you include a discussion of the device characteristics that address the risks identified in this guidance document and any additional risks identified in your risk analysis.
Description of the performance aspects We recommend that you include a brief description of the test method s that you used or intend to use that address each performance aspect identified in Sections of this guidance document.
If you follow a suggested test method, you may cite the method rather than describing it. If you modify a suggested test method, you may cite the method but should provide sufficient information to explain the nature of and reason for the modification. For each test, you may either 1 briefly present the data resulting from the test in clear and concise form, such as a table, or 2 describe the acceptance criteria that you will apply to your test results.
Reliance on standards If any part of the device design or testing relies on a recognized standard, FDA recommends that you submit either:. Because a declaration of conformity is based on results from testing, we believe you cannot properly submit a declaration of conformity until you have completed the testing the standard describes.
We may request additional information to assess the adequacy of your acceptance criteria. Under 21 CFR As an alternative to submitting an Abbreviated k , submission of a Traditional k that provides all of the information and data required under 21 CFR A Traditional k should include all of your methods, data, acceptance criteria, and conclusions.
Manufacturers considering modifications to their own cleared devices should consider submitting Special k s. See also Appendix A. The following is a specific discussion of how you should apply this guidance document to k s for menstrual tampons or pads. Scented or scented-deodorized menstrual pads and unscented menstrual pads, made of materials with established safety profiles and that are not intralabial pads or reusable menstrual pads 5 are excluded from the scope of this guidance because they are exempt from k.
Generally, FDA believes a material has an established safety profile if it has a history of safe use for similar intended uses and is physically and chemically well-characterized. The characterization of the material may be in the published literature, a previous submission, or a Device Master file.
An intralabial pad is a menstrual pad intended worn externally and held in place by the labia. A reusable pad is one that may be washed, dried, and used again by the same woman. The scope of this document is limited to the devices shown in the Table 1 below. See Combination Products for more information. We recommend that you identify your device by regulation and product code.
We also recommend that you provide a complete discussion of the design features, indications, and performance characteristics of your device. You should discuss the similarities and differences between your device and the predicate device in sufficient detail to permit FDA to fully assess your device and its similarities with the predicate device.
We also recommend that you describe how any differences may affect the safety and effectiveness of your device. We recommend that you include the following in your discussion. Tampons FDA recommends that you include engineering drawings of the tampon. We also recommend that you show the dimensions and materials for the:. FDA also recommends that you provide a cross-sectional drawing to illustrate the design and dimensions of the tampon, both compressed and uncompressed.
Pads FDA recommends that you include engineering drawings of the pad. Tampons We recommend that you provide specifications, including tolerances for the weight of the pledget in grams , for each absorbency range of tampon in your submission.
Pads Absorbency range as described in 21 CFR See Design and Dimensions above instead. For all component materials present in a tampon, applicator, or pad, we recommend that you provide:.
We recommend that you summarize the information recommended above in a tabular format to show how your device compares with the predicate device see sample format below. In the table below, FDA has identified the risks to health generally associated with the use of the menstrual tampons and pads within the scope of this document. The measures recommended to mitigate these risks are also shown in the table.
You should also conduct a risk analysis, before submitting your k , to identify any other risks specific to your device, especially if your device has any innovative or special features. The k should describe the risk analysis method and submit the results. If you elect to use an alternative approach to address a particular risk identified in this document, or have identified risks additional to those in this document, you should provide sufficient detail to support the approach you have used to address that risk.
We recommend you provide a summary of this testing in your submission for each absorbency level you plan to market.
You should describe any assurances that chemical residues are not present or, if residues are present, the level present and the method used to assess it. These assurances may include, but are not limited to, test methods, tolerances, or acceptance criteria. For any materials bleached during processing, we recommend that you identify the bleaching process used, e.
FDA also recommends that you demonstrate the performance characteristics for the following features of tampons:. For any pad materials that are bleached during processing, we recommend that you identify the bleaching process used, e.
In addition, FDA recommends that you demonstrate any device performance characteristics described in the labeling for such pads, such as washability or useable life. Generally, we anticipate the performance characteristics of these devices will be unique. The Obstetrics and Gynecology Devices Branch is available to discuss bench testing for your device before you prepare your k. We recommend that you select biocompatibility tests appropriate for the duration and level of contact with your device.
If identical materials are used in a predicate device with the same type and duration of user contact, you may identify the predicate device in lieu of providing biocompatibility testing in your submission. For tampon materials, we recommend that you demonstrate that the tampon, in its final manufactured form, does not:. There are no reference methods or recognized standards for testing S. We have included several methods in Appendix B. References , and 9. We recommend that you specify the test conditions, including cell culture medium and strains of S.
While, in general, clinical studies will not be needed for most menstrual tampons and pads, FDA may recommend that you collect clinical data for menstrual tampons including applicators, if present or pads with:. FDA will always consider alternatives to clinical testing when the proposed alternatives are supported by an adequate scientific rationale. The Obstetrics and Gynecology Devices Branch is available to discuss any questions you may have.