American Podiatric Medical Association

SEAL OF ACCEPTANCE

PROGRAM GUIDELINES

American Podiatric Medical Association

CONTENTS

I.The APMA Seal of Acceptance………………………………………. 1

  1. Value of the APMA Seal of Acceptance……………………………… 1
  1. APMA’s Committee on Podiatric Seals……………………………… 1
IV.Confidentiality of Submission Materials…………………………….. 2
  1. Qualifying for the APMA Seal of Acceptance………………………. 2
  1. Product Categories……………………………………………………. 2
  1. Provisions for Acceptance…………………………………………….. 3
  1. Conditions……………………………………………………………… 5
  1. Revocation of Acceptance……………………………………………... 6
  1. Reconsideration Process………………………………………………. 6
accepted
American Podiatric medical association

I.THE APMA SEAL OF ACCEPTANCE

The American Podiatric Medical Association (APMA) established the Seal Program more than 25 years ago. The APMA Seal Program was created to inform both podiatric physicians and consumers about products whose quality, safety, and effectiveness allow for normal foot function and promote good foot health.

The APMA Seal Program is strictly voluntary and more than 300 products carry the Seal. In order to be granted the Seal, there are certain requirements that must be met. Every foot care product is scientifically evaluated and not every product is granted the Seal. The APMA Seal is awarded for up to a three-year period. Renewal of the Seal of Acceptance will be considered by the APMA upon request by the manufacturer.

  1. VALUE OF THE APMA SEAL OF ACCEPTANCE

The value of the Seal of Acceptance is two-fold. First, and foremost, it is the desire of the American Podiatric Medical Association (APMA) to provide information for podiatric physicians and their patients, and for the general public to ensure that they can make the best possible decisions regarding foot health. Because podiatrists (doctors of podiatric medicine) provide the majority of all foot care services rendered in the nation. APMA has accepted the responsibility of informing Americans of the importance of recognizing and maintaining comfortable foot health. A major goal of APMA is to raise awareness by identifying products of exceptional quality that are manufactured with the consumer’s comfort, and safety in mind.

Second, as part of its long history of supporting preventive medicine and good foot health, APMA has a responsibility to assist the public in making informed decisions about foot health. The APMA believes that this service is appreciated and needed in order to keep America walking on a firm foundation.

  1. APMA’S COMMITTEE ON

PODIATRIC SEALS

The Committee on Podiatric Seals is comprised of doctors of podiatric medicine. The Committee is charged with the responsibility of reviewing footwear, materials, equipment, and hosiery that are used in the practice of podiatric medicine and/or that influence public foot health.

  1. CONFIDENTIALITY OF SUBMISSION MATERIALS

All submitted materials and supporting documentations regarding a product for the APMA Seal of Acceptance are considered confidential. The APMA requires its committee members to sign a Confidentiality Agreement, which prohibits them from disclosing to anyone outside the APMA any materials and/or supporting documentation regarding a product. However, the Association is not liable to the applicant for any damages resulting from the acts or omissions of APMA committee members, including, but not limited to, their failure to abide by the Confidentiality Agreement.

All proceedings of the Committee on Podiatric Seals and the APMA Board of Trustees with respect to applications, reports, and communications regarding the review and consideration of any product are considered confidential.

  1. QUALIFYING FOR THE APMA SEAL OF ACCEPTANCE

The seal of acceptance is granted when evidence of safety and effectiveness of a product has been established by an appropriately recognized laboratory and/or clinical investigation and/or when physical standards and/or specifications applicable to footwear under consideration have been met. In addition, the Seal may be granted when products promote normal foot function and quality foot health. Products that are primarily cosmetic shall not be considered acceptable for the Seal. Consideration of granting the Seal of Acceptance pertains to market ready products only; no prototypes will be considered.

  1. PRODUCT CATEGORIES GRANTED THE SEAL OF ACCEPTANCE

MATERIALS:

Those materials used in the production of footwear and/or used by the public and/or used by the podiatric physician for the treatment of conditions of the human foot and ankle.

SHOES, HOSIERY, AND INSOLES:

Those forms of footwear which are used by the public and recommended by the podiatric physician.

EQUIPMENT:

Foot health related equipment for direct consumer use or professional use in the delivery of foot care.

  1. PROVISIONS FOR ACCEPTANCE

The following list of procedures and criteria constitute the requirements for an application for the Seal of Acceptance and, when applicable, for maintaining recognition over the term for which the Seal is extended. The APMA reserves the right to modify these provisions at any time. Companies that have received the Seal of Acceptance are expected to stay abreast of changes in these provisions.

  1. All communications shall be written and directed to:

Director of Health Affairs

C/O Committee on Podiatric Seals

American Podiatric Medical Association

9312 Old Georgetown Road

Bethesda, MD 20814-1698

Any effort to contact a member of the Committee during the review process will result in the immediate termination of the application.

  1. Submit ten (10) copies of the completed application along with ten (10) copies of all additional documentation in support of the application. All materials must be in English. Separate application forms are required for additional submissions. The Committee will review only completed applications.
  2. Submit (10) original trade package items produced for market for each submission. All materials submitted for review become the property of APMA.
  3. Submit the necessary application and processing fees (please see enclosed fee schedule).
  4. Required documentary evidence regarding composition, physical, and chemical properties.
  1. Required documentary evidence for shoes – a detailed description of each component used including, but not limited to the upper, insole, outsole, shank, construction, and lining. The manufacturer must provide heel height, if applicable. The manufacturer must supply properties and satisfactory compliance with the appropriate United States regulatory standards for any chemical(s) used.
  2. Required documentary evidence for materials, hosiery, insoles, and equipment – a detailed description of each component of the product, including a breakdown of component percentages. The manufacturer must supply properties and satisfactory compliance with the appropriate United States regulatory standards for any chemical(s).
  1. Provide documentary evidence of product safety and efficacy. Evidence pertaining to the mechanical and physical properties and operating characteristics, when applicable, shall be submitted. The company must provide timely and objective, not subjective, data from clinical and/or laboratory studies. Test results must be summarized.
  2. The Committee reserves the right to utilize an independent laboratory, institution, and/or testing facility to confirm any or all claims made by the applicant, the expense of such testing to be borne by the applicant.
  3. Provide documentary evidence that manufacturing facilities are properly supervised to assure quality and uniformity of product.
  4. Quality control systems utilized by the manufacturer must be provided including yearly product return rate and reason.
  5. Any adverse effects related to the use of the product(s) reported to the applicant shall be communicated to the Committee.
  6. Products shall conform to all applicable United States laws and governmental regulations.
  7. All labeling, package inserts, advertising and promotional materials must be approved by the Committee on Podiatric Seals as substantiated by the applicant with objective data from clinical and/or laboratory studies. Only those claims that can be supported by appropriate clinical and/or laboratory studies and scientific data are allowed.
  8. Following the granting of the Seal of Acceptance, Seal holding companies have the following continuing obligations during the term of recognition:
  1. Submit an annual report form by December 1 (copy of the form to be provided by APMA).
  2. Report immediately any changes in the composition, style, nature, function, name, or intended use of the product.
  3. Report immediately any adverse effects related to the use of the product(s).
  4. Submit the yearly maintenance fee (please see enclosed fee schedule).
  1. The APMA Seal of Acceptance may be awarded for a period of up to three years. Renewal is required for continued recognition, including submission of an application for renewal.

Please allow three months from the date of receipt of a completed application to the Committee for product evaluation. More time may be required for the review process if additional information is required or in the case of multiple submissions.

  1. CONDITIONS FOR THE USE AND PROMOTION OF THE SEAL OF ACCEPTANCE

The Seal shall not be used until after the manufacturer has been notified in writing that the product has been Accepted by the APMA Board of Trustees and after both the manufacturer and APMA have executed the “Agreement for Use of the Seal of Acceptance.”

Companies or individuals whose product(s) have been granted the Seal of Acceptance are required to use the Seal logo, and no other medical seal, when promoting their product(s). The Seal logo may not be altered in any manner except in size.

The Seal may be used on product labeling inserts, advertising and promotional material.

The APMA Seal may not be used in conjunction with Seals from other associations.

The APMA Seal is given only to products and not to companies. In no way may the Seal be used for other products not accepted by the APMA, nor shall it be advertised or displayed with unaccepted products in a manner that implies acceptance of the unaccepted product. The provision does not apply to conventional price lists or catalogs.

The responsibility of providing substantiation of claims for safety and efficacy or claims of compliance with an official standard shall reside solely with the manufacturer and not with the American Podiatric Medical Association.

The Seal may be used in advertising only in conjunction with claims allowed by the Committee. Any misleading or deceptive use of the Seal in advertising as perceived by the Committee on Podiatric Seals, may be cause for revocation of the Seal. Product advertising and promotional materials must be in good taste.

Whenever the composition of an accepted product changes, the manufacturer must resubmit the product for review and approval before it is marketed with the Seal. As long as a product bears the Seal, it must continue to meet all requirements specified in this document.

The Seal is owned by the American Podiatric Medical Association and is a federally registered trademark.

  1. REVOCATION OF ACCEPTANCE

The Committee on Podiatric Seals may on occasion find it necessary to review the status of a product’s acceptance and recommend revocation to the APMA Board of Trustees. Decisions of the Committee are based upon available scientific evidence and are subject to reconsideration at any time that a significant amount of new evidence becomes available. If current scientific evidence demonstrates that a product is no longer safe or effective, or if a product is obsolete, markedly inferior, or dangerous to the health of the user, it will be declared unaccepted and the Seal will be revoked.

Any violation of the Conditions for Use and Promotion of the Seal of Acceptance also will be considered grounds for revocation of product acceptance.

The company may be given six months from the date of such revocation to use existing labeling, package inserts, or similar supplies. The Committee reserves the right to require a shorter time frame for removal of the Seal from existing products if it is determined that the safety and efficacy of the product have been diminished or if the company has misused the Seal of Acceptance or if the company has failed to pay its required fee.

  1. RECONSIDERATION PROCESS

The Committee on Podiatric Seals will explain in writing its rationale and reasons for denying the Seal of Acceptance. Thereafter, a company has the right to request in writing within 30 days, reconsideration of the decision. Such a request must be addressed to the Chairman of the Committee on Podiatric Seals and must include specific reasons why the Committee should reconsider its decision. The request also must include ten (10) copies of any new data or documentation pertaining to the product that the company would like to have evaluated by the Committee during its reconsideration. The Committee may request additional information from the company in order to evaluate the request for reconsideration. A reconsideration fee may apply.

Appropriate requests for reconsideration and sufficient data/documentation will be presented to the Committee for its consideration. The Committee’s decision will be relayed to the company in writing with an appropriate explanation. The Committee’s decision shall be final; and, if the action to deny is sustained, no further consideration will occur.

SEAL OF ACCEPTANCE APPLICATION FOR EQUIPMENT

1.Name of Product (one application is required for each product submission).

______.

  1. Name of Company ______.

Address: ______.

______.

______.

Telephone: (______)______.

Fax: (______)______.

E-mail: ______.

Website: ______.

Contact person(s): ______.

______.

  1. Names of owners, officers, or other individuals authorized to furnish information and represent the company to the Seal Committee:

______.

______.

  1. Names and qualifications of scientific personnel responsible for research, development, and testing of submitted product – please attach resume(s).

______.

______.

  1. Intended Use of Product: ______.

______.

______.

  1. Patent(s): ______.

______.

  1. Composition of Product (company must list all components used in construction of the product): ______.

______.

______.

  1. Glossary of Terms: ______.

______.

______.

  1. Suggested Retail Price: ______.
  1. Evidence of Safety – all safety information must be provided (i.e., Material Safety Data Sheet, EPA/FDA approval document, where appropriate).

______.

______.

  1. Evidence of Quality Control Procedures: ______.

______.

______.

  1. Research Documentation – all objective testing, reports, studies, or significant articles done on a component or on the entire product must be provided.

______.

______.

  1. Ten copies of all current promotional materials (i.e., catalogs, dealer sheets, advertising materials).
  1. Ten samples of products (please call the Department of Health Affairs for additional information).
  1. Please include any other materials which applicant deems helpful to the committee.

I certify that the information given on or attached to this application is accurate and complete to the best of my knowledge. I fully understand and agree that as a condition to making this application, any misrepresentation or misstatements in or omissions from it, whether intentional or not, shall constitute cause for automatic and immediate rejection of this application. I agree to all the terms and conditions of the Seal of Acceptance Program. The APMA assumes no responsibility for claims and other statements made by the awardee on its product literature accompanying the product, or its advertising and promotional materials, or harmless from any and all claims or liabilities in connection therewith.

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