Inspections, Compliance, Enforcement, and Criminal Investigations
Rapid Recovery Health Services Inc. Company Response Letter
Rapid Recovery Health Services
March 23, 2005
William MacFarland, Chief
Orthopedic, Physical Medicine &
Anesthesiology Devices Branch HFZ-343
Division of Enforcement B, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850
Dear Mr. MacFarland:
We are writing in response to your Warning Letter dated March 7, 2004 in which you referenced our website, www.rapidrecoveryinc.com Specifically, you stated that our website was not compliant with current Food and Drug Administration (FDA) regulations with respect to the promotion of extracorporeal shockwave therapy (ESWT) through the use of the Sonocur® and the Epos Ultra medical devices. Upon receipt of your letter, we reviewed our website and have initiated the following correction steps to ensure that our website addresses you letter and is compliant with FDA regulations.
First, we have retained a law firm to provide us counsel related to the promotion and marketing of ESWT as well as applicable medical devices. Such counseling will include our website as well as other modes of communication with physicians and consumers . We have informed the law firm of all current marketing activities with respect to ESWT and will notify the law firm of all future marketing proposals prior to finalization to ensure compliance with applicable FDA regulations.
Second, we are currently in the process of modifying our website to address the items stated in the letter as well as other applicable FDA regulations. Any reference to unapproved indications of the Sonococ® and/or the Epos Ultra will be promptly deleted. In addition, the website is being modified to clearly differentiate between the intended uses of the Sonocur® and the Epos Ultra. For example, the website will reference the use of the Sonocure solely for the treatment of chronic lateral epicondylitis (commonly referred to as tennis elbow) for patients with symptoms of chronic lateral epicondylitis for six (6) months or more and a history of unsuccessful conservative treatments. Further, the website will reference the Epos Ultra solely for the treatment of chronic plantar fasciitis for patients with symptoms of plantar fasciitis for six (6) months or more and a history of unsuccessful conservative therapy. We also intend to include a list of frequently asked questions related to the Epos Ultra, which will reference information from the professional and/or patient labeling found on the FDA website. Note that the website currently includes frequently- asked questions related to the Sonocur®, which includes information from its corresponding label.
We believe that these correction action steps will address your concerns regarding our website's current and future compliance with FDA regulations. Please do not hesitate to contact me should you need further information or clarification regarding the foregoing.