Department of Health and Human Services
Public Health Service
19900 MacArthur Blvd #300
July 23, 1997
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Erik K. Affholter, Member Manager
Bio Magnetics International, LLC
1836 Mesa Ridge Ave
West Lake Village, CA 91362
Ref. No. 31-7
Dear Mr Affholter:
We are writing to you because on April 29, 1997, an investigator from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the products known as Magnetic Belts and Straps which are made and marketed by your firm.
Under a United States Federal law, the Federal Food, Drug, and Cosmetic Act (the Act), these products are considered to be medical devices because they are used to diagnose or treat a medical condition or to affect the structure or fhnction of the body. The law requires that manufacturers of medical devices obtain marketing clearance for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be either safe and effective or substantially equivalent to other devices already legally marketed in this country. Our records do not show that you obtained marketing clearance before you began offering your products for sale. The kind of information you need to submit in order to obtain this clearance is described in the enclosed materials. The FDA will evaluate this infm-mation and decide whether your product may be legally marketed.
Because you do not have marketing clearance from FDA, marketing your product is a violation of the law. In legal terms the products are adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act. Your products are adulterated under the Act because you did not obtain premarket approval based on information developed by you that show your devices are safe and effective. Your products are misbranded under the Act because you did not submit information that shows your devices are substantially equivalent to other devices that are legally marketed.
You should know that this serious violation of the law may result in FDA taking regulatory action without fhrther notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. Also, other Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.
It is necessary for you to take action on this matter now. Please let this office know in writing within fifteen (15) working days from the date you received this letter what steps you are taking to correct the problem. We also ask that you explain how you plan to prevent this 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 Dannie E. Rowland, Compliance Officer, US Food and Drug Administration, 19900 MacArthur Blvd #300, Irvine, CA 92612-2445.
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 for your device 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 Assistance at 800-638-2041 or through the Internet at www.fda.gov.
If you have any more specific questions about how FDA marketing requirements affect your particular device, or about the content of this letter, please feel free to contact Dannie E. Rowland at 714-798-7649.
Elaine C. Messa
This page was posted on August 20, 2006.