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Document issued on: July 23, 1998
U.S. Department Of Health And Human Services
Obstetric and Gynecology Devices Branch |
Comments and suggestions may be submitted at any time for Agency consideration to, Colin M. Pollard, Chief, Obstetrics and Gynecology Devices Branch (OGDB), HFZ-470, 9200 Corporate Blvd., Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance, contact Mr. Colin M. Pollard at 240-276-4155 or by electronic mail, at colin.pollard@fda.hhs.gov.
World Wide Web/CDRH home page: http://www.fda.gov/cdrh, or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 1250 when prompted for the document shelf number.
This guidance document represents the agency's current thinking on the use of consensus standards for abbreviated submissions for 510(k) Premarket notifications for latex condoms for men. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Latex Condoms for Men
Information for 510(k) Premarket Notifications:
Use of Consensus Standards for Abbreviated Submissions
Section 510(k) of the Act and the implementing regulation, 21 CFR Part 807, require persons who intend to market a new device to submit a premarket notification containing information that enables FDA to determine whether the new device is substantially equivalent within the meaning of Section 513(i) of the Act to a legally marketed device that does not require premarket approval. Unless exempted from premarket notification requirements, persons may not market a new device under Section 510(k) of the Act, unless they receive a substantial equivalence order from FDA or an order reclassifying the device into Class I or Class II (section 513(i) of the Act). Male condoms are classified as Class II devices under 21 CFR �4.5300 and �4.5310 (Condom with spermicidal lubricant) and are not exempted from 510(k) requirements, therefore, a 510(k) premarket notification must be cleared by order of FDA before a new male condom, or one that has been significantly changed or modified, is introduced into interstate commerce.
A person required to submit a 510(k) premarket notification must provide information as required by the statute and regulations to allow the Center to make an appropriate decision regarding the clearance of the submission.
The Center believes that conformance with recognized consensus standards can provide a reasonable assurance of safety and/or effectiveness for many aspects of medical devices, including Male Latex Condoms. A 510(k) that contains a declaration of conformity to recognized consensus standards, as discussed below, will, in most cases, eliminate the need to review the actual test data for those aspects of the device addressed by the standards. This, however, does not affect the Center's ability to obtain any information authorized by the statute or regulations. Conformance with recognized consensus standards in and of itself may not always be a sufficient basis for regulatory decisions. For example, a specific device and/or intended use may raise safety or effectiveness issues not addressed by any recognized consensus standard, or a specific FDA regulation may require additional information beyond what conformity to recognized consensus standards provide. Under such circumstances, conformity with recognized standards will not satisfy all requirements for marketing the latex condom in the United States.
The Center for Devices and Radiological Health has recognized and will use consensus standards pursuant to the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), which amends section 514 of the Food, Drug, and Cosmetic Act (21 U.S.C. 514(c)). FDA has recognized voluntary consensus standards for Latex Condoms for Men, and other relevant standards may also be applicable to the submission of a 510(k) for a latex condom, e.g., ISO 10993. A list of recognized standards is maintained on the CDRH website and is updated at least annually. Other recognized standards may be applicable for latex condoms and manufacturers have the right to make a declaration of conformity to any listed standard. [FDA Guidance on the Recognition and Use of Consensus Standards, February 19, 1998, q.v.]
Building on FDA's recognition of the ASTM voluntary consensus standard for condoms and the ISO voluntary consensus standard for biological evaluation of medical devices, this guidance document provides an outline for a 510(k) premarket notification that incorporates a declaration of conformance with these standards. When the declaration is combined in a 510(k) which is complete and accurate, it can serve as the basis for an FDA finding of substantial equivalence for a Natural Rubber Latex (NRL) Condom. (Other criteria exist for blends and non-NRL Male Condoms and for Female Condoms.)
<< Cover Letter >>
[Date of Submission] | ||
| ||
Re: |
Abbreviated 510(k) Notification [Brand Name] Male Latex Condom |
Dear Sir or Madam:
This submission is being made in compliance with Section 510(k) of the Food, Drug and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990 and the Food and Drug Administration Modernization Act of 1997, and the Office of Device Evaluation guidance for Abbreviated 510(k) requirements for a male latex condom. The enclosed information is being submitted for the [Brand Name] Male Latex Condom, which is made from Natural Rubber Latex. Two copies of this Premarket Notification are being submitted in accordance with 21 CFR 807.
The purpose of this submission is to notify FDA, in accordance with the 510(k) provisions of the Act, of our intent to introduce this [new product, the... /or/ modification of the currently marketed] [Brand Name] Male Condom into commercial distribution.
If you have any questions regarding this submission, please telephone [contact person's name] at [(area) phone number].
Sincerely yours,
[Name] [Title] |
PREMARKET NOTIFICATION
TRUTHFUL AND ACCURATE STATEMENT
[Refer to �7.85(j)]
I certify, in my capacity as [Title], that I believe, to the best of my knowledge, that all data and information submitted in this 510(k) Premarket Notification Submission is truthful and accurate and that no material fact has been omitted.
[signature] | |
| |
[Name] | |
[Title] | |
[date] | |
....................................... | |
Date |
I. GENERAL INFORMATION
q | Initial Product Introduction | |
|
New Model for Product-line Extension | |
Initial Import into the USA |
||
Other (Include in Part IV an explanation referenced to Part I.H.) |
NOTE: |
Provide the information required by 21 CFR �7.92, OR the 510(k) Statement (Option 2) on the next page. |
II. 510(k) SUMMARY (Option 1)
Submitted by: |
[Company] |
Contact Person: |
[Individual's Name] |
Date Prepared: |
[Date] |
Proprietary Name: |
[Brand Name of Condom] |
Common Name: |
Latex Condom |
Classification Name: |
Condom (21 CFR �4.5300) |
Predicate Device: |
Latex Lubricated Condom |
Description of the Device: This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom [include a brief description of the condom, such as, a straight-walled, nipple-end, nominal length, nominal width, nominal thickness, etc].
Intended Use of the Device: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.)
Technological Characteristics: [Indicate whether the condom has the same technological characteristics as the predicate condom identified above. Indicate that the design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex. Summarize the similarities and differences of the features and technological characteristics of the condom in comparison to the predicate condom.]
II. 510(k) STATEMENT (Option 2)
[Refer to �7.93]
I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent in the firm), of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
.
Certified: |
________[Signed]________________ |
_________[Date]_________________ |
III. DECLARATION of CONFORMANCE with CONSENSUS STANDARDS
Requirement* |
SO STIPULATED** |
AT VARIANCE*** | ||
1. |
Manufactured from good quality natural rubber latex.(ammoniated), conforming to Specification ASTM D 1076-97 |
1. |
||
2. | Meets criteria that toxic, sensitizing, locally |
2. |
||
3. | Minimum length is 160 mm |
3. |
||
4. |
Maximum width is 54 mm |
4. |
||
5. | Minimum thickness is 0.03 mm |
5. |
||
6. | Air Burst Test Pressure |
6. |
||
7. | Air Burst Test Volume |
7. |
||
8. | Leakage AQL |
8. |
||
9. | Package integrity AQL |
9. |
Requirement* |
SO STIPULATED** |
AT VARIANCE*** | ||
1. |
ISO 10993-5 -- Cytotoxicity |
1. |
||
2. | ISO 10993-10 -- Irritation and Sensitization |
2. |
||
3.
| ISO 10993-11 -- Systemic Toxicity |
3. |
||
4. | ISO 10993-12 -- Sample Preparation and Reference Materials |
4. |
The ISO 10993 standard describes test methods, but does not specify performance limits for each test. Therefore, data summaries and results of the above safety testing are included in Part IV.
* |
ASTM -- American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428; (610) 832-9500. Refer to full text of ASTM D3492 for the specific requirements that apply. |
** |
Certifying signature required on next page of this Part. |
*** |
Include (under a separate section, identified with the item number) information, data, and analyses appropriately describing and explaining variance from standard; include rationale for variance and justification why this variance does not have a material impact on the substantial equivalence of the condom. |
|
_________________________________ |
[Name] |
|
_________________________________ |
Date |
When there is a third-party certifying laboratory or certification body, provide the names and addresses and a reference to any accreditation of each laboratory. Certification statements should also be included.
IV. DESCRIPTION OF DEVICE
V. STATEMENT OF SUBSTANTIAL EQUIVALENCE
Indicate whether the condom has the same intended use and technological characteristics as the predicate condom. Summarize the similarities and differences of the features and technological characteristics of the condom in comparison to the predicate condom.
VI. LABELS, LABELING AND ADVERTISEMENTS
Provide proposed labels, labeling and advertisements sufficient to describe the device, its intended use, and the directions for use. (21 CFR 807.87(e)) For overall labeling guidance, manufacturers are encouraged to consult with FDA's manual "Labeling: Regulatory Requirements for Medical Devices," (HHS Publication FDA 89-4203). (Also see Title 21 CFR �1, �1.435 and �1.437.) Labeling for latex condoms should include but not be limited to the following:
If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
The following expanded statement should be added to the package insert, directions for use:
If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
This product combines a latex condom and a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if some semen spills or seeps outside the condom. However, the extent of decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom.
See ODE guidance entitled "Uniform Contraceptive Labeling: Guidance To Industry."
Precautions
Directions for Use
CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX
WHICH MAY CAUSE ALLERGIC REACTIONS
This statement must appear on all device labels, and other labeling, and shall appear on the principal display panel of the device packaging, the outside package, container or wrapper, and the immediate device package, container or wrapper. This final rule has an effective date of September 30, 1998. This labeling requirement is considered necessary because devices composed of, or containing, natural rubber latex, pose a significant health risk to some individuals. (See also, FDA's March 29, 1991, FDA Medical Alert, Allergic Reactions to Latex Containing Medical Devices. MDA91-1.)
VII. INDICATIONS FOR USE STATEMENT
510(k) Number: |
(if known) |
Device Name: |
[Brand Name] Male Natural Rubber Latex Condom |
Indications For Use: |
The [Brand Name] condom is used for contraception and for |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
__________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ___________ |
OR | Over-The-Counter Use___________ |
Tab 1 - Device Description
Provide a diagram (or diagrams) of the subject latex condom. The diagram should show key dimensions, as well as relevant contours.
Provide all relevant product specifications that adequately characterize the condom. Given below is an example of how this information should be given.
Typical (Average) Product Characteristics
Tab 2 - Compounded Latex Formulation
Provide a complete summary of the compounded latex formulation and other materials used in the manufacture of the condom. Given below is an example to illustrate how this information should be given.
TABLE 1 - Compounded Latex Formulation Summary
Generic Name & Chemical Composition |
CAS No |
Percentage |
Function |
Natural Rubber Latex (cis-1,4-polyisoprene) |
100.00 |
||
Diisopropyl xanthogen polysulfide |
-- |
Vulcanizing agent (cross-linking) | |
Sulfur |
-- |
Vulcanizing agent (cross-linking) | |
Zinc Oxide |
-- |
Activator | |
Zinc-N-diethyl-dithio-carbomate |
-- |
Accelerator | |
Zinc-N-dibutyl-dithio-carbomate |
-- |
Accelerator | |
Potassium Hydroxide |
-- |
Stabilizing agent | |
Sodium lauryl sulfate |
-- |
Emulsifier | |
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt |
-- |
Emulsifier | |
Ammonia |
Preservative | ||
Formaldehyde |
Preservative | ||
-- |
Antioxidant | ||
-- |
Anti-ozonants | ||
|
TABLE 2 - Compounded Formulation Condom Additives
Generic Name & Chemical Composition |
Supplier |
CAS No. |
Amount (mg) |
Dusting Agents |
|||
U.S.P. Corn Starch |
|||
Lubricants |
|||
Silicone (polydimethylsiloxane) |
|||
Nonoxynol-9 |
|||
TABLE 3 - Condom Composition Summary - Colors
Color |
Pigment |
C.I. No. |
CAS Reg. No. |
21 CFR Citation |
Amount PPH latex |
Red |
C.I. Pigment Red 48:2 Permanent Carmine |
C.I.#12490 |
73.100 |
||
Blue |
C.I. Pigment Blue 15:2/Copper Phthalocyanine Blue |
C.I. #74160 |
CAS Reg No.147-14-8 |
178.3297(e) |
|
Green |
C.I. Pigment Green 7/Polychloro Copper Phthalocyanine Green |
C.I. #74260 |
CAS Reg No.1328-53-6 |
178.3297(e) |
|
Yellow |
C.I. Pigment Yellow 74 |
C.I. #11741 |
CAS Reg No.6358-31-2 |
177.2600 |
|
Uploaded on December 3, 1998
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