Inspections, Compliance, Enforcement, and Criminal Investigations
Rapid Recovery Health Services Inc. FDA Response Letter
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|2098 Gaither Road
Rockville MD 20850
FEB 22 2006
VIA FEDERAL EXPRESS
Mr. Scott Warantz
Rapid Recovery Health Services Inc.
30 Hopper Street
Westbury, New York 11590
Dear Mr. Scott Warantz:
This is in response to your letter dated March 23, 2005 and your 2005, counsel's letters dated April l5, April 20, 2005 and May 26, 2005. These letters responded to our March 7, 2005 Warning Letter to your firm. The Warning Letter covers your website, www .ranidrecoveryin c.com, relating to extracorporeal shockwave therapy (ESWT) devices. The website promotes the Sonocur© for the relief of pain from chronic lateral epicondylitis and the Epos Ultra for the relief of pain from chronic plantar fasciitis . Below is our assessment of the adequacy of your response.
The following paragraphs outline each charge under sections 501(f)(1)(B) and 502(o) of the Act, as given in the March 7, 2005, Warning Letter. Following the charge is a summary of your response and our assessment.
1. Failure to obtain FDA premarket approval for unapproved indications for the Sonocur and Epos Ultra, as required under section 501(f)(1)(B) of the Act. For example, your website stated that the ESWT devices could be used to treat pain in the hand/wrist, shoulder, or knee/heel, or other tendon-related problems which were not included in the PMAs approved for these devices.
You have removed the unapproved indications for the use of the ESWT devices from your website and have retained counsel to ensure that your website as well as other promotional material is in compliance with the FDA regulations. In addition, you have detailed how you plan to perform internal audits quarterly on the website and your promotional material.
The responses received March 23, 2005, April 15, 2005, April 20, 2005, and May 26, 2005, are adequate. The indications for use that have not been approved for these ESWT devices have been removed from your website and your promotional materials. In addition, you have outlined other corrective actions that are being taken to prevent any further adulteration under section 501(f)(1)(B) of the Act. Procedures identifying how the website and promotional materials will be monitored and audited have also been included.
2. Failure to notify the agency of your intent to introduce the devices into commercial distribution as required under section 510(k) of the Act. For example, your website offered the Sonocur and the Epos Ultra for sale for the treatment of pain in a PMA.
Your March 23, 2005, April 15, 2005, April 20, 2005, and May 26, 2005, responses are adequate. You have removed the unapproved indications from your website and have provided your corrective actions that include training, auditing and monitoring of the website to prevent future noncompliance. The Employee Education and Orientation Plan has been provided and outlines how employees are trained to prevent future promotion of the devices for unapproved indications. Also, the procedures for monitoring and auditing the website and promotional material for noncompliance have been included. This procedures indicates, "Only FDA approved indications, relevant warnings, precautions, side effects and contraindications as referenced in the corresponding device's approval letter, professional labeling and/or patient labeling shall be permitted on the website."
Your responses appear to have adequately addressed our concerns. At this time, you are not required to submit a further response to this office.
If you have any questions concerning the contents of this letter, please do not hesitate to contact William MacFarland at (240) 276-0120.
Division of Enforcement B
Office of Compliance
Center for Devices and