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Dr Nelson Clinic .com LFT 9000 FDA information |
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Dr Mark Nelson Foot & Ankle Specialist
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Light Force Therapy received a FDA letter regarding the marketing of it's products, such as the LFT 9000, which is being sold in TV infomercials. The letter is posted below. It is unknown, since the date of this letter, if the company has taken correctional measures to comply with the FDA requirements.
MAY 4 2004 WARNING LETTER VIA FEDERAL EXPRESS Ms. Kimberly Peterson Dear Ms. Peterson: We are writing to you because your firm is marketing infrared lamp devices known as the “LFT 9000,” “Dio LFT 3000,” and “Super Nova” for new intended uses that were not cleared or approved by the Food and Drug Administration (FDA). In addition, we believe that certain of your current labeling materials contain false or misleading statements or information. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), these products are medical devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. The law requires that manufacturers of medical devices obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that newly-introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country. A review of FDA databases disclosed that your firm obtained premarket notification (510(k)) clearances for the “Super Nova,” “Acubeam,” “Acubeam LFT 5000,” and “Dio LFT 3000” devices (K001179 and K022888). It is our understanding that your firm no longer sells the Acubeam or Acubeam LFT 5000. The LFT 9000 appears to be an updated model of the Acubeam LFT 5000 that does not require a separate premarket submission prior to commercial distribution for the same indications for which FDA cleared the Acubeam LFT 5000. FDA cleared the Super Nova and Acubeam (K001179) for the following intended uses:
FDA cleared the Acubeam LFT 5000, Dio LFT 3000, and Super Nova (for one additional indication) (K022888) for the following intended uses:
All claims in your labeling and promotional materials must be limited to the cleared indications listed above. However, our review of the following materials revealed that your labeling and promotional materials go beyond these cleared indications:
These items make statements about intended uses for the LFT 9000, Dio LFT 3000, and/or the Super Nova for which you do not have FDA clearance or approval. Examples of such statements include, but are not limited to, the following:
These indications constitute major changes or modifications in the cleared intended uses of your products, and therefore require a new premarket submission prior to marketing your devices for these new indications. 21 CFR 807.81(a)(3)(ii). Guidance regarding the kind of information you need to submit to FDA in order to obtain clearance or approval for the additional indications is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. Your promotion and introduction into interstate commerce of the LFT 9000, Dio LFT 3000, and Super Nova for uncleared indications violates the law. Specifically, these products are adulterated under section 501 (f)(1)(B) of the Act because you do not have an approved Premarket Approval Application (PMA) to demonstrate that these products are safe and effective for the new uses for which you are marketing them. In addition, the devices are misbranded under section 502(o) of the Act because you have not submitted a section 510(k) premarket notification to the agency of your intent to introduce the devices into commercial distribution for these new uses. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81 (b). During several previous communications with your firm and its representatives, FDA advised you that certain intended uses for which you are now promoting your devices could not be included under your 510(k) clearances. For instance, prior to clearance of 510(k) number K001179, FDA required you to modify indications for “pain” to “minor muscle and joint” pain. With regard to 510(k) number K022888, your firm’s representative (Mr. Lewis Ward of L.W. Ward and Associates) agreed in a November 14, 2002 facsimile to several changes urged by FDA, including the addition of the word “minor” to the indication for joint and muscle pain, and to the removal of your proposed “chronic pain” indication. Furthermore, the labeling materials listed above as items 1-4 appear to contain false or misleading statements or information, which include but are not limited to the following examples:
Your website, the information packet (e.g., a four-page brochure), the informational video, and the instructional video constitute labeling as defined under section 201 (m) of the Act, and the false and misleading statements therein render your devices misbranded under section 502(a) of the Act. The false and misleading statements specified above, and any similar statements, as well as the letter incorrectly identified as an FDA endorsement of your products, must be removed from the website, the four-page brochure, the videos, your infomercial, and any similar materials you provide to customers or prospective customers. You should know that these are serious violations of the law that may result in FDA taking regulatory action against you or your product without further notice if you do not act promptly. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of your products, or assessing civil money penalties. Also, federal agencies are informed about Warning Letters such as this one, so that they may consider this information when awarding government contracts. It is necessary for you to take action on these matters now. Please let this office know what steps you have taken to correct these problems within fifteen (15) working days from the date you receive this letter. We also ask that you explain how you plan to prevent these problems from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response to:
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter pertains only to the issue of premarket clearance or approval and subsequent promotion of your devices and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA’s requirements for manufacturers of medical devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or through the Internet at http://www.fda.gov. If you have more specific questions about how FDA marketing and other requirements affect your particular devices, or about the content of this letter, please feel free to contact William Defibaugh at (301) 594-4660, extension 121. Sincerely yours, /s/ Timothy A. Ulatowski |
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