Guidance for Industry and FDA Staff 
 
Menstrual Tampons and Pads: 

Information for Premarket 

Notification Submissions (510(k)s) 
 
Document issued on: July 27, 2005 
 
 
For questions regarding this document contact Colin Pollard at 240-276-4155 or by email at 
colin.pollard@fda.hhs.gov. 

 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Obstetrics & Gynecology Devices Branch 
Division of Reproductive, Abdominal, and Radiological Devices 
Office of Device Evaluation 
 
 
 
 
  Contains Nonbinding Recommendations 
 
 
Preface
  
 
Public Comment  
 
Written comments and suggestions may be submitted at any time for Agency consideration to the 
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852. 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  
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/ode/guidance/166.pdf, or to receive this document via your fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. Press 1 to enter the system.  At the second voice prompt, press 1 to order 
a document.  Enter the document number (166) followed by the pound sign (#). Follow the 
remaining voice prompts to complete your request.   
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
1.  INTRODUCTION..............................................................................................................................................1
  
2.  BACKGROUND ................................................................................................................................................2
  
3.  THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION..................................2
  
4.  SCOPE ................................................................................................................................................................5
  
5.  DEVICE DESCRIPTION .................................................................................................................................7
  
A.  DESIGN AND DIMENSIONS ................................................................................................................................7
  
B.  ABSORBENCY RANGE.......................................................................................................................................7
  
C.  COMPONENT MATERIALS (INCLUDING ADDITIVES)..........................................................................................8
  
6.  RISKS TO HEALTH .........................................................................................................................................9
  
7.  PERFORMANCE CHARACTERISTICS ....................................................................................................10
  
A.  TAMPONS .......................................................................................................................................................10
  
B.  PADS ..............................................................................................................................................................11
  
8.  PRECLINICAL TOXICOLOGY...................................................................................................................11
  
9.  PRECLINICAL MICROBIOLOGY .............................................................................................................11
  
10.  CLINICAL STUDIES.................................................................................................................................12 
 
11.  LABELING..................................................................................................................................................13
  
A.  TAMPONS AND PADS ......................................................................................................................................14
  
B.  TAMPONS ONLY .............................................................................................................................................14
  
APPENDIX A.  MODIFYING A LEGALLY MARKETED TAMPON..............................................................15 
 
APPENDIX B.  REFERENCES...............................................................................................................................16
  
 
  Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff 

 
 
 
Menstrual Tampons and Pads: Information for 
Premarket Notification Submissions (510(k)s) 

 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic. 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. 
 
1.   Introduction
FDA has developed this guidance document to assist industry in preparing premarket notification 
submissions (510(k)) for menstrual tampons and pads that are subject to 510(k) requirements.
  
This guidance covers the key recommendations for the content of 510(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.  If, however, you believe that there is a less 
burdensome way to address the issues, you should follow the procedures outlined in the A 
Suggested Approach to Resolving Least Burdensome Issues document.  It is available on our 
Center web page at:https://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM588914.pdf. 
  1  Contains Nonbinding Recommendations 
 
 
2.  Background
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 807 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. Scope). 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 510(k).  You should also refer to CDRHs Device Advice  
http://www.fda.gov/cdrh/devadvice/ and 21 CFR 807.87. 
 
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications; Final Guidance1, a manufacturer may submit a 
Traditional 510(k) or has the option of submitting either an Abbreviated 510(k) or a Special 
510(k). FDA believes an Abbreviated 510(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 510(k). 
 
3.  The Content and Format of an Abbreviated 510(k)
Submission
An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 
807.87, including the proposed labeling for the device sufficient to describe the device, its 
intended use, and the directions for its use. In an Abbreviated 510(k), FDA may consider the 
contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 
807.87(f) or (g); therefore, we recommend that you include a summary report.  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 807.87, as well as some other items that we recommend you include in an 
Abbreviated 510(k). 
 
Coversheet 
                                                 
1  http://www.fda.gov/cdrh/ode/parad510.html  
  2  Contains Nonbinding Recommendations 
 
The coversheet should prominently identify the submission as an Abbreviated 510(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 11. Labeling for specific information that  
should be included in the labeling for devices of the types covered by this guidance 
document.) 
 
Summary report 
We recommend that the summary report contain the following. 
 
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.) You should also submit an indications for use enclosure.2    
 
Description of device design requirements 
We recommend that you include a brief description of the device design requirements. 
 
Identification of the risk analysis method 
We recommend that you identify the risk analysis method(s) used to assess the risk 
profile for both the general and specific devices design. 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.) 
 
                                                 
2 Refer to  http://www.fda.gov/cdrh/ode/indicate.html for the recommended format. 
 
  3  Contains Nonbinding Recommendations 
 
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 7-10 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.3  (See also 21 CFR 820.30, Subpart C - Design 
Controls under the Quality System Regulation.) 
 
Reliance on standards 
If any part of the device design or testing relies on a recognized standard, FDA 
recommends that you submit either:  
 
	   a statement that the device will meet specified acceptance criteria through testing 
prior to product marketing; or  
 
	   a declaration of conformity to the standard.4    
 
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. For more information, please refer to section 514(c)(1)(B) of the 
Act and the FDA guidance, Use of Standards in Substantial Equivalence 
Determinations; Final Guidance for Industry and FDA, 
http://www.fda.gov/cdrh/ode/guidance/1131.html. 
 
If you do not clearly address the risks identified either by FDA (see Table- Risks and 
Mitigation Measures) or through your risk analysis, FDA may request additional information 
                                                 
3 If FDA makes a substantial equivalence determination based on acceptance criteria, the subject 
device should be tested and shown to meet these acceptance criteria before being introduced into 
interstate commerce.  If the finished device does not meet the acceptance criteria and, thus, 
differs from the device described in the cleared 510(k), FDA recommends that submitters apply 
the same criteria used to assess modifications to legally marketed devices (21 CFR 807.81(a)(3)) 
to determine whether marketing of the finished device requires clearance of a new 510(k). 
4 See Required Elements for a Declaration of Conformity to a Recognized Standard  (Screening 
Checklist for All Premarket Notification [510(K)] Submissions), 
http://www.fda.gov/cdrh/ode/reqrecstand.html. 
  4  Contains Nonbinding Recommendations 
 
about aspects of the devices performance characteristics.  We may request additional 
information to assess the adequacy of your acceptance criteria.  (Under 21 CFR 807.87(l), FDA 
may request any additional information that is necessary to reach a determination regarding 
substantial equivalence.) 
 
As an alternative to submitting an Abbreviated 510(k), submission of a Traditional 510(k) that 
provides all of the information and data required under 21 CFR 807.87 and described in this 
guidance will suffice. A Traditional 510(k) should include all of your methods, data, acceptance 
criteria, and conclusions. Manufacturers considering modifications to their own cleared devices 
should consider submitting Special 510(k)s.  See also Appendix A. 
 
The following is a specific discussion of how you should apply this guidance document to 
510(k)s for menstrual tampons or pads.  
 
4.  Scope
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 pads5 are 
excluded from the scope of this guidance because they are exempt from 510(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.6    
 
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. 
Table 1. Classification and Product Codes for Menstrual Tampons and Pads subject to 
this guidance. 
                                                 
5 Scented or scented-deodorized menstrual pads that are not intralabial pads or reusable 
menstrual pads, made of materials with established safety profiles are classified in 21 CFR 
884.5425 and assigned product code NRC. Unscented menstrual pads that are not intralabial 
pads or reusable menstrual pads, made of materials with established safety profiles are classified 
in 21 CFR 884.5435 and assigned product code HHD.
6 Although traditionally referenced to support Premarket Approval Applications (PMAs), 
Master Files may also be referenced to support 510(k)s.  For information about Device 
Master Files, see 21 CFR 814.3(d) and Device Advice at 
http://www.fda.gov/cdrh/dsma/pmaman/appdxc.html#P7_2. 
 
  5  Contains Nonbinding Recommendations 
 
Classification  Product 
Class  Description 
Regulation (21 CFR)  Code 
884.5425 Scented or  II  HHL  Scented or scented-deodorized menstrual pads, 
scented-deodorized  including those intended as intralabial pads or 
menstrual pad7   reusable menstrual pads, made with materials or 
additives that do not have an established safety 
profile.8    
I  Not yet  Scented or scented-deodorized menstrual pads 
assigned  intended as intralabial pads or reusable menstrual 
pads, including those made with materials or additives 
with established safety profiles. 
884.5435 Unscented  I  NUR  Unscented menstrual pad intended as an intralabial 
menstrual pad7   pad. 
NUQ  Unscented menstrual pad intended as a reusable pad. 
Not yet  Unscented menstrual pad made with materials or 
assigned  additives that do not have an established safety profile 
884.5460 Scented or  II  HIL  Scented or scented-deodorized menstrual tampon*   
scented-deodorized   
menstrual tampon 
884.5470 Unscented  II  HEB  Unscented menstrual tampon*   
menstrual tampon 
*If your device contains a drug or biologic, it is a combination product.  See
http://www.fda.gov/oc/combination/ for more information. 
 
                                                 
7We believe typographical errors (intralabial and [intralabial]) were introduced when these 
classifications were amended (65 FR 2296, 2320 and 66 FR 38786, 38809).  Both classifications 
should refer to intralabial pads as stated in the unamended classification (61 FR 67713, 67714). 

We plan to publish a correction in the Federal Register as soon as feasible. 

8 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. 

  6  Contains Nonbinding Recommendations 
 
5.  Device Description
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. 
A.  Design and Dimensions
Tampons 
FDA recommends that you include engineering drawings of the tampon.  We also 
recommend that you show the dimensions and materials for the:  
  pledget
  overwrap (cover)
  removal string
  applicator (if any).
 
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.  We also 
recommend that you show the dimensions and materials for the:  
  core
  overwrap (cover).
B.  Absorbency Range
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 
  7  Contains Nonbinding Recommendations 
 
Absorbency range as described in 21 CFR 801.430 does not apply to pads. See 
Design and Dimensions above instead.  
C.  Component Materials (including Additives)
For all component materials present in a tampon, applicator, or pad, we recommend that you 
provide: 
 
  detailed chemical identity and quantity (in g per tampon or pad) for all
components, and any additives or finishing (e.g., anti-wicking) agents
 
  chemical identity of each component of any fragrance or deodorants
 
  references to any Device Master Files6 for component materials, whenever possible.
 
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).   
 
Table 2. Device Comparison  
Predicate 
Element   Your Device   (with 510(k) number, if 
available)  
Design (e.g., shape of the tampon and     
applicator, if present) 
Dimensions     
   length
   diameter (tampons only)
Absorbency (grams) for each level     
(tampons only)  
 
Component Materials (chemical    *  
composition)  
 
Additives and Finishing Agents    *  
 
Other Features (if any)     
 
*(to the extent this information is available to you for devices made by other manufacturers) 
 
  8  Contains Nonbinding Recommendations 
 
6.  Risks to Health
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 510(k), to identify any other risks specific to your device, especially if your 
device has any innovative or special features. The 510(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. 
 
Table 3. Menstrual Tampons - Risks and Mitigation Measures 
Recommended mitigation measures 
Identified risk 
(see section indicated below)  
7. Performance Characteristics
8. Preclinical Toxicology
adverse tissue reaction 
10. Clinical Studies
11. Labeling
10. Clinical Studies
vaginal injury 
11. Labeling
vaginal infection  11. Labeling 
9. Preclinical Microbiology
toxic shock syndrome (TSS) 
11. Labeling
 
 
Table 4. Menstrual Pads - Risks and Mitigation Measures 
Recommended mitigation measures 
Identified risk 
(see section indicated below)  
 
7. Performance Characteristics
adverse tissue reaction 
11. Labeling
 
 
  9  Contains Nonbinding Recommendations 
 
7.  Performance Characteristics
A.  Tampons
Absorbency Range
Tampons must be labeled in accordance with 21 CFR 801.430.  To determine the 
absorbency of menstrual tampons, you must use the Syngyna testing method as 
specified in 21 CFR 801.430(f)(2). We recommend you provide a summary of this 
testing in your submission for each absorbency level you plan to market.   
 
Chemical Residues 
FDA recommends that tampons be free of 2,3,7,8- tetrachlorodibenzo-p-dioxin 

(TCDD)/2,3,7,8-tetrachlorofuran dioxin (TCDF) and any pesticide and herbicide 
residues.9   
 
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.g., Elemental Chlorine-Free (ECF) or Totally Chlorine-Free (TCF).   
 
FDA also recommends that you demonstrate the performance characteristics for the 
following features of tampons: 
 
  string strength
  fiber shedding
  tampon integrity.
                                                 
9  FDA recommends that as a part of your design validation, you have in place validated test 
plans for monitoring dioxin and potential pesticide residues for cotton in tampon materials and 
final finished tampons.  We recommend that you evaluate your device as described in your test 
plans and identify the test method and name and address of the testing laboratory in your design 
history file. You should also explain in your design history file whether testing was conducted 
on a prototype, on select or all batches, and on a fixed or as needed schedule. For more 
information on design validation and design history files, please see 21 CFR Part 820 Quality 
Systems.   
 
  10  Contains Nonbinding Recommendations 
 
B.  Pads
For any pad materials that are bleached during processing, we recommend that you identify 
the bleaching process used, e.g., Elemental Chlorine-Free (ECF) or Totally Chlorine-Free 
(TCF). 
 
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 510(k). 
 
8.   Preclinical Toxicology
For tampons and pads, we recommend that you conduct biocompatibility testing as described in 
the FDA guidance, Use of International Standard ISO-10993, Biological Evaluation of 
Medical Devices Part-1: Evaluation and Testing, https://www.fda.gov/downloads/
medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf (for repea t 
use devices--30 days or more-- in contact with skin/mucosal membrane surface).  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. 
 
9.  Preclinical Microbiology
For tampon materials, we recommend that you demonstrate that the tampon, in its final 
manufactured form, does not:   
  enhance the growth of Staphylococcus aureus
  increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
  alter the growth of normal vaginal microflora.
 
There are no reference methods or recognized standards for testing S. aureus in tampons.  We  
have included several methods in Appendix B. References 2-7, and 9. We recommend that 
you specify the test conditions, including cell culture medium and strains of S. aureus and other 
microorganisms used, and reference the methodology.   
 
TSS is not a concern with the use of menstrual pads.  
 
  11  Contains Nonbinding Recommendations 
 
10.  Clinical Studies
In accordance with the least burdensome provisions of the Act, FDA will rely upon well-
designed bench and/or animal testing rather than requiring clinical studies for new devices unless 
there is a specific justification for asking for clinical information to support a determination of 
substantial equivalence. 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: 
  designs or material formulations10 dissimilar from designs or material formulations used
in legally marketed devices of the same type
  new technology, i.e., technology different from that used in legally marketed devices of
the same type
  indications for use dissimilar from legally marketed devices of the same type.
 
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. 
If clinical studies are necessary, we recommend that the studies evaluate: 
  irritation
  allergy
  effects on vaginal microflora
  abrasions
  ulceration
  laceration
  residual fiber retention.
 
For any clinical study involving ultra absorbency tampons (i.e., 15-18 grams determined by 
Syngyna testing, as defined in 21 CFR 801.430), we recommend that you provide clinical 
information on fiber sloughing in vivo, in addition to the information above.  If you have already 
begun marketing your ultra absorbency tampon in another country, we recommend that you 
include any published literature related to the use of your ultra absorbency tampon, in 
particular any literature related to that tampon and TSS. 
 
                                                 
10If your device contains a drug or biologic, it is a combination product.  See 
http://www.fda.gov/oc/combination/ for more information. 

 
  12  Contains Nonbinding Recommendations 
 
If subjects undergo a colposcopic examination during your clinical study to assess vaginal 
mucosa integrity, redness, and irritation or residual fiber retention related to tampon use, we 
recommend these examinations be conducted before and after the menses.  We also recommend 
that these examinations be conducted by a healthcare professional.  For guidance on conducting 
colposcopic examinations, please see Manual for the Standardization of Colposcopy for the 
Evaluation of Vaginal Products, Update 2000. 11  
 
FDA believes that the devices addressed in this guidance document are non-significant risk 
(NSR) devices. Therefore studies of these devices are subject to the abbreviated requirements of 
21 CFR 812.2(b). In addition to the requirements of section 21 CFR 812.2(b), sponsors of such 
trials must comply with the regulations governing institutional review boards (21 CFR Part 56) 
and informed consent (21 CFR Part 50). 
 
As stated in 21 CFR 812.2(b), we consider studies on NSR devices to have approved 
applications for investigational device exemptions (IDEs), unless we have notified the sponsor 
otherwise. However, you may choose to submit a pre-IDE to help identify deficiencies that 
could preclude clearance of the resulting 510(k). You may submit a pre-IDE even though you 
are not going to submit an IDE to FDA.  In this case, the pre-IDE should describe your study 
design, clinical protocol, and statistical plan, thus allowing the Obstetrics and Gynecology 
Devices Branch an opportunity to comment on these important elements before you initiate your 
study.12  
 
After FDA determines that the device is substantially equivalent, clinical studies conducted in 
accordance with the indications reviewed in the 510(k), including clinical design validation 
studies conducted in accordance with the quality systems regulation, are exempt from the 
investigational device exemptions (IDE) requirements.  However, such studies must be 
performed in conformance with 21 CFR 56 and 21 CFR 50. 
 
11.  Labeling
The premarket notification should include labeling in sufficient detail to satisfy the requirements 
of 21 CFR 807.87(e). The following suggestions offer assistance in preparing labeling that 
satisfies the requirements of 21 CFR Part 801.13   
                                                 
11 Reference WHO/RHR/00.11 - CONRAD/2000.1, http://www.who.int/reproductive
health/publications/Abstracts/colposcopy_evaluation.html 
12 See also Pre-IDE Program: Issues and Answers, March 25, 1999 (D99-1), 
http://www.fda.gov/cdrh/ode/d99-1.html. 
13 Although final labeling is not required for 510(k) clearance, final labeling must comply with 
the requirements of 21 CFR 801 before a medical device is introduced into interstate commerce.  
For tampons, this includes complying with 21 CFR 801.430, User labeling for menstrual 
tampons.  Labeling recommendations in this guidance are consistent with the requirements of 
part 801. 
  13  Contains Nonbinding Recommendations 
 
A.  Tampons and Pads
User instructions for menstrual tampons and pads should familiarize users with the features 
of the device and how to use it in a safe and effective manner and include a description of the 
product and the materials it contains. 
B.  Tampons only
For menstrual tampons, in addition to the labeling information required by 21 CFR 
801.430(d) and 21 CFR 801.430(e), user instructions should include information on: 
  selection of tampon size and absorbency
  tampon insertion
  how tampon should be worn and wear-time
  tampon removal and disposal.
To avoid risk of TSS, we recommend that you include instructions that: 
  limit wear-time per tampon to no more than 8 hours
  advise against the use of tampons overnight.
 
Rates of reported TSS cases associated with tampons have decreased significantly over the 
past 20 years (Reference 8). We believe more informative tampon labeling and educational 
efforts by the FDA and tampon manufacturers have played key roles in this decrease.  
Therefore, FDA recommends continued caution when developing tampon labeling.14   
 
For scented or scented-deodorized tampons, we also recommend that you include a warning 
statement about allergic reactions and irritations, for example: 
 
If an allergic reaction or irritation occurs from using tampons, you should discontinue use 
and consult a medical professional. 
 
 
                                                                                                                                                             
 
14 We recommend that you draft labeling that helps ensure consumer (adult and teen) 
comprehension of safety information about tampons and TSS, as well as helps avoid unintended 
effects on consumer behavior that might increase the risk of TSS.  We recommend that you 
document the results of any evaluation such as focus testing in your design history file.   
  14  Contains Nonbinding Recommendations 
 
Appendix A.  Modifying a Legally Marketed Tampon 
If you change or modify your legally marketed device in a way that significantly affects its 
safety or effectiveness, you must submit a new 510(k).  21 CFR 807.81(a)(3). Generally, FDA 
believes the modifications listed below significantly affect the safety or effectiveness of a 
tampon: 
  dissimilar indications for use
  new device materials or additives
  modifications resulting in a design that is dissimilar from the legally marketed design
  modification of a legally marketed tampon to achieve a 15-18 gram absorbency (as
shown by Syngyna test).
 
FDA believes that the modifications listed below generally do not affect safety and 
effectiveness: 
  changing ratios of absorbent materials in tampon pledget. For example, changing from 
50/50 cotton and rayon to 80% cotton and 20% rayon.15   
  adding an absorbency range, other than ultra (15-18 gram) to a manufacturers legally
marketed design, consistent with the absorbency ranges specified in 21 CFR
801.430(e)(1).
When a modification does not affect the intended use or alter the fundamental scientific 
technology of the device, but requires a new 510(k) in accordance with 21 CFR 
807.81(a)(3), FDA recommends you submit a Special 510(k).16    
 
In any 510(k) for a change or modification to a legally marketed tampon, we recommend 
that you describe the modification and its effects and provide supporting information 
(such as a risk analysis, performance characteristics, or preclinical or clinical information) 
demonstrating that the modification does not adversely affect safety or effectiveness.  For 
additional guidance about modifying legally marketed devices, please see Deciding 
When to Submit a 510(k) for a Change to an Existing Device  
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/
guidancedocuments/ucm514737.pdf. 
                                                 
15 If the absorbency range changes as a result, we recommend that you document these changes 
in your design history file.

16 See The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications; Final Guidance, 

http://www.fda.gov/cdrh/ode/parad510.html. 

 
  15  Contains Nonbinding Recommendations 
 
 
Appendix B.  References 
1. 	  Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products, 
Update 2000, WHO. 
 
2. 	  Schlivert PM, Blomster DA. Production of staphylococcal pyrogenic exotoxin type C: 
influence of physical and chemical factors.  J Infect Dis 1983; 147:236-42. 
 
3. 	  Kass EH, Schlivert PM, Parsonnet J, Mills JT. Effect of magnesium on production of 
toxic-shock-syndrome toxin-1: a collaborative study. J Infect Dis 1988;158:44-51. 
 
4. 	  Melish ME, Murata S, Fukunga C, Frogner K, McKissick C. Vaginal tampon model for 
toxic shock syndrome. Rev Infect Dis 1989;11 Suppl 1:S238-46; discussion S246-7. 
 
5. 	  Schlivert PM. Composition of cotton and cotton/rayon tampon for effect on production of 
toxic shock syndrome toxin. J Infect Dis 1995;172:112-4. 
 
6. 	  Parsonnet J, Modern PA, Giacobbe KD. Effect of tampon composition on production of 
toxic shock syndrome toxin-1 by Staphylococcus aureus in vitro.  J Infect Dis 1996; 
173:98-103. 
 
7. 	  Lee Wong AC and Downs SA. Investigation by improved syringe method of effects of 
tampon on production of toxic shock syndrome toxin-1 by  Staphylococcus aureus. J. 
Cln. Microb. 1989; 2482-87. 
 
8. 	  Hajjeh RA, Reingold A, Weil A, Shutt K, Schuchat A,and Perkins BA.  Toxic shock 
syndrome in the United States: Surveillance update.  Emerging Infectious Diseases 1999; 
5: 807-810. 
 
9. 	  Flood J.A., Tripp T.J., Davis C.C., Hill D.R., Schlievert P.M. A toroid model for in vitro 
investigations of toxic shock syndrome toxin-1 production. Journal of Microbiological 
Methods 2004, 5: Issue 2; 283-288. 
 
 
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