Canadian Federation of Podiatric Medicine Seal of Approval Application Information Canadian Federation of Podiatric Medicine 200 King Street South, Waterloo, ON N2J 1P9 Phone: 888-706-4444 Fax 519-888-9385 Canadian Federation of Podiatric Medicine CFPM Seal of Approval Helping the public and podiatric medicine professionals make informed choices. The Canadian Federation of Podiatric Medicine (CFPM) Consumer Product Approval (CPR) and Professional Products Approval (PPR) programs provide valuable information to both the podiatric medicine professional and the consumer about a wide variety of products whose quality, safety and effectiveness allow for normal foot function and good foot health. These products are of value when used in a conscientious applied program of foot health and regular professional care. About the Seal The CFPM Seal of Approval is a symbol of products that are of benefit to the foot health of consumers. The Seal is designed to help the public and the podiatric medical professional make informed choices. The CFPM Seal Program is strictly voluntary and in order for a product to be granted the Seal, certain requirements must be met. Every foot care product is scientifically evaluated and not every product is granted the Seal. The CFPM Seal is awarded for up to a three year period with a yearly fee, and renewal will be considered by the CFPM upon request by the manufacturer. Value of the CFPM Seal of Approval The value of the CFPM Seal of Approval is many faceted. First, it is the desire of the Canadian Federation of Podiatric Medicine (CFPM) to provide the best possible information to the podiatric medicine professional and their patients, and for the general public to ensure that they can make the best possible decision regarding foot health. Because podiatric medicine practitioners (Podiatrists & Chiropodists) provide the most comprehensive level of medical foot care in the country, part of the responsibilities of the CFPM is to inform Canadians of the importance of maintaining good foot health. Part of this foot health awareness would come by identifying products of exceptional quality and are manufactured with the consumer’s safety and comfort in mind. For the manufacturer, market research on products recognized by other medical organizations, has demonstrated that a Seal of Approval directly affects the purchasing decisions of consumers and medical professionals, who equate such a Seal as an indication of quality and effectiveness. CFPM Committee on Seal of Approval The Committee on the Seal of Approval is comprised of Chiropodists and Podiatrists (DCh, DPodM, DPM, DP, BSc Pod Med) who will review and make recommendations in writing on the products tested to the Board of the CFPM for final approval. The committee will be made of three to five members and can consist of both members of the CFPM board and general members of the CFPM. One CFPM Board member will chair the committee. This is a voluntary, unpaid position for one year renewable duration of term. Members who have a potential conflict of interest or financial gains must declare and disclosed this information and may be removed temporarily from the committee for those items being reviewed. The committee will be in charge of scientifically reviewing products, footwear, hosiery, materials and equipment that are used in the practice of podiatric medicine and /or influence public foot health. Committee members’ identities will not be disclosed to the applicant. Following the extensive review process, and based on the recommendations from the Committee on Seal Approval, the board of the CFPM with communicate in writing to those who have been successful in the process. Not every product is granted a Seal. Confidentiality of Submission Materials All submitted materials and supporting documentation for a product being considered for a CFPM Seal of Approval are considered confidential. All members of the committee will sign a confidentiality agreement for their term served, which will prohibit them from disclosing to anyone outside of the CFPM Board any materials and supporting documentation regarding a product. However, the CFPM is not liable to the applicant for damages resulting from omissions or committee members’ failure to abide by the confidentiality agreement. Qualifying for the CFPM Seal of Approval The Seal of Approval is granted when safety and effectiveness of a product has been established by an appropriate laboratory, clinical investigation or when physical and/or quality standards have been met. In addition the Seal of Approval may be granted when a product promotes normal foot function and quality foot health. Consideration for the Seal will only be accepted for market ready products. Product Categories granted for the Seal of Approval Consumer Products Categories for the Consumer Product Approval program (CPR) are selected to educate the public and professionals about specific aspects of consumer products. The CFPM recognizes products in the following categories. Medicated wart therapies: These products contain ingredients that when used as recommended are safe and effective home therapies for the common human papilloma virus. Medicated and non-medicated corn therapies: These products contain ingredients or qualities that when used as recommended are safe and effective home therapies for the treatment of corns. Cleansers: These products contain ingredients that when used as recommended can help cleanse the skin and reduce the microbial load and/or aid in the overall foot health. Bandages and dressings: The CFPM recognizes products that are effective at covering wounds and aid in wound healing. Anti-fungal medications: These products contain ingredients that when used as recommended are safe and effective home therapies for the treatment of fungal infections of the skin and/or the nails. Emollients: The CFPM recognizes products that show effective treatment of dry or damaged skin and/or contain medical ingredients that demonstrate improved results for various skin conditions. Hosiery: The CFPM recognizes products recommended by podiatric medical professionals for compression therapy, circulation problems, diabetes and/or better overall foot health. Shoes: The CFPM recognizes products recommended by podiatric medicine professionals and used by the general public that exhibit properties or qualities which aid in the overall foot health of the Canadian population. Insoles and arch supports: The CFPM recognizes products recommended by podiatric medicine professionals and used by the general public that are durable, supportive and exhibit documented properties or qualities which aid in the overall foot health of the Canadian population. Public education: The CFPM recognizes programs that promote good foot health among Canadians. Professional Products Categories for the Professional Product Approval program (PPR) are selected to recognize products used Chiropodists/Podiatrists in their practices. The CFPM recognizes products in the following categories: Durable Medical products: This category includes, but is not limited to, products used daily in the podiatric medical practice in the delivery of foot care. These items demonstrate effectiveness, reliability, quality and value to the practitioner in providing treatment and include such items as gloves, blades, gauze, tapes, masks and other such sundry items. Equipment: This category includes, but is not limited to, products used daily in the podiatric medical practice in the delivery of foot care. These items demonstrate effectiveness, reliability, quality and value to the practitioner in providing treatment and include such items as chairs, drills, lighting, and physical therapy equipment. Computer programs: The CFPM recognizes computer systems that help in the proper operation of a podiatric medical office and aid in the effective scheduling, billing and data collection to deliver a high level of foot health care to Canadians. Orthotics and orthotic labs: The CFPM recognizes orthotic labs that follow proper manufacture and quality protocols, practice ethical business practices and whose products are soundly designed, used good quality materials, demonstrate innovation in design and value to the podiatric medicine specialist. How to Apply The following is a list of procedures and criteria required for an application for a CFPM Seal of Approval. The CFPM reserves the right to modify these provisions at any time and companies who have been granted the Seal of Approval are expected to stay abreast of these changes in provision. 1. All applications and communications shall be written and directed to: Seal of Approval Committee Canadian Federation of Podiatric Medicine 200 King Street South Waterloo, Ontario N2J 1P9 2. Submit five (5) copies of the completed application along with five (5) copies of documentation in support of application. Separate applications are required for additional submissions. Only complete applications will be considered. 3. Submit five (5) original trade packaged items produced for the Canadian market, including all labelling, package inserts, advertising and promotional materials. Sizing will be provided by the CFPM in the case of consumer products such as shoes, hosiery and shoe inserts. In the case of custom orthotics, samples may be sent, or custom items manufactured specifically for members of the evaluation committee. If deemed necessary, members of the CFPM evaluation committee shall reserve the right to do an on-site visit and evaluation of any orthotic laboratory applying for the seal. All travel costs relating to such a visit shall be the responsibility of the applicant. In the case of large equipment or computer systems, these items may be set up for demonstrated, provided for a short term trial and/or examined in an appropriate setting by members of the committee for CFPM Seal of Approval as coordinated by the CFPM. All non-equipment/computer submitted items become the property of the CFPM. 4. Submit the necessary application and processing fees. (See enclosed fee schedule) 5. Required documentary evidence includes: - Documented evidence of product safety and efficacy. These shall include objective data collected from clinical and/or laboratory studies. The committee reserves the right to utilize an independent laboratory or testing facility to confirm any claims made by the applicants at the applicant’s expense. - Provide documentation that the product complies with all requirements of Health Canada and that any adverse effects related to the use of the product is reported and communicated to the consumer and the committee. - That the product can be legally sold in Canada under the category specified in the application and that the product conforms to all Canadian laws. - That effective quality control systems are utilized in the manufacture of the product. - Submit product specifications, ingredient lists and any other pertinent information for review and approval. - Not a prescription product. 6. Following granting of the CFPM Seal of Approval companies are required to continue for the term of the Seal of Approval to provide: - Annual reports to the CFPM reporting ,if any, changes to the composition, style, nature, function, name or intended use of the product. Report any adverse effects related to the use of the product(s). - Submit yearly renewal fees. 7. The CFPM Seal of Approval can be awarded for up to a three year period. Renewal is required yearly to continue approval under this program. Once your application for the Seal of Approval has been received, please allow three months for product evaluation by the committee. More than one item to be evaluated from one company or products that require further information may require longer periods of time for the review process to be completed. Conditions of Use for the CFPM Seal of Approval 1. The Seal of Approval may not be used until the manufacturer has been notified in writing of acceptance by the board of the CFPM and not until after the manufacturer and the CFPM have executed the “Agreement for use of the CFPM Seal of Approval”. 2. The Seal may be used on product labelling, inserts, advertising and promotional materials. The logo may not be altered in any manner except size or colour. 3. The CFPM Seal of Approval cannot be used in conjunction with Seals from other associations without direct written consent of the board of the CFPM. 4. The CFPM Seal of Approval is given to products and not companies. In no way shall the Seal be used in conjunction with other products not accepted by the CFPM and not advertised in such a way as to imply such acceptance. This provision does not apply to price lists or catalogues. 5. Any misleading or deceptive use of the Seal in advertising as perceived by the CFPM Committee of Seal Acceptance may cause the revocation of the Seal. 6. Responsibility for the substantiation of claims of safety and/or efficacy resides solely with the manufacturer and not with the CFPM. 7. For as long as the product bears the CFPM Seal of Approval, it must continue to meet all of the requirements of this document. Any change in composition of the product by the manufacturer, requires that they resubmit the product for approval before it can be marketed with the Seal. 8. The Seal is owned by the Canadian Federation of Podiatric Medicine. Revocation of the CFPM Seal of Approval On occasion the Committee on the CFPM Seal of Approval may find it necessary to review the status of product acceptance and recommend revocation to the board of the CFPM. Decisions are made on available scientific evidence and if current scientific evidence demonstrates that the product is no longer safe or effective or if a product is obsolete, inferior or dangerous it will be deemed unacceptable and the Seal will be revoked. Violations of the conditions of use will also be considered grounds for revocation of the Seal. The company will be given six months from the date of revocation to use up all packaging, labels, inserts or similar items. Shorter periods may be requested at the discretion of the board of the CFPM if the product is deemed dangerous to the general public or if there has been gross misuse of the Seal of Approval or the company has failed to pay their annual fees. Any company which has had the Seal revoked will have 30 days from the date of revocation to provide in writing why the committee shall review their decision. Such written documentation must include five (5) copies of any new data the company wishes the committee to review and specific reasons why the committee should reconsider its decision. Appropriate requests with sufficient data shall be passed along to the committee for review and the committee’s decision will be relayed to the company in writing. The committee’s decision will be final. Benefits of the CFPM Seal of Approval 1. Announcement of awarding of the Seal in the CFPM journal, with distribution to all members and students. 2. Provide access to CFPM membership for promotional purposes. 3. Promote Seal holding companies on web site and through inquiries to CFPM offices. 4. Provide Seal in a digital format for internet and external corporate promotion. 5. Provide Seal holders booth recognition markers at CFPM trade shows. 6. Provide Seal holders a 20% discount for advertising in the CFPM Journal, as well as a 20% discount on booths at the CFPM annual conference. 7. Promote professional purchase programs or discount offers to CFPM members. Canadian Federation of Podiatric Medicine Seal of Approval Fee Schedule The schedule below lists the application, processing and maintenance fees for the CFPM Seal of approval. Application and processing fees are one time fees and should be paid at the time of submitting a completed application form and is required before the product evaluation can begin. Maintenance fees are billed yearly on November 1st. Application fee: A $500.00 fee is required with each single or multiple submissions. Processing Fee: A $1,000 fee is required for each single submission. A $1,500 fee is required for multiple submissions of two to four products. A $2,000 fee is required for multiple submissions of five to seven products. A $3,500 fee is required for multiple submissions of eight to nine products. A $5,000 fee is required for multiple submissions of ten to fourteen products. A $6,500 fee is required for multiple submissions of fifteen to twenty products. An $8,000 fee is required for multiple submissions of twenty one to twenty five products. A $10,000 fee is required for multiple submissions of more then twenty five products. Yearly Renewal Fees: Yearly Renewal fees are billed yearly on November 1st for the three year life of the seal. For one to four products $ 1,750 For five to nine products $2,000 For ten or more products $2,500 Application for CFPM Seal of Approval 1. Name of product (One application is required for each product submission) 2. Name of Company________________________________________________________________ Address__________________________________________________________________________ _________________________________________________________________________________ Telephone__________________________ Fax______________________________ E-mail______________________________ Website__________________________ Contact person(s) __________________________________________________________________ 3. Names of owners, officers or other individuals authorized to furnish information and represent the company to the Seal of Approval Committee ____________________________________________________________________________________ ____________________________________________________________________________________ 4. Intended use of product : Consumer Product Approval program (CPR) Professional Product Approval program (PPR) ____________________________________________________________________________________ ____________________________________________________________________________________ 5. Patent(s) _______________________________________________________________________ ____________________________________________________________________________________ 6. Composition of product (please list and provide any supporting documentation) ____________________________________________________________________________________ 7. Research Documentation- all objective testing, reports, studies or significant articles performed on components or entire product _______________________________________________________ ____________________________________________________________________________________ ____________________________________________________________________________________ 8. Evidence of Safety (Health Canada approval, material safety data sheets where appropriate) ____________________________________________________________________________________ ____________________________________________________________________________________ 9. Suggested retail price ___________________________________________________________ 10. Five copies of all current promotional materials (catalogues, advertising materials). 11. Five samples of the product (for products requiring sizing please contact the CFPM for information). 12. Please include any other materials which may be helpful to the committee to properly assess the product. I certify that all information provided or attached to this application is accurate and complete to the best of my knowledge. I agree to all of the terms and conditions of the CFPM Seal of Approval acceptance program. Signature ______________________________________________ Date __________________ Print Name ________________________________________________________________________
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