• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

3TP, LLC Response Letter

October 25, 2004

 

Mr. William C. Maloney

Physicist

Diagnostic Devices Branch (HFZ-322)

Food and Drug Administration

Center for Devices and Radiological Health

2098 Gaither Road

Rockville, MD 20850

 

Dear Mr. Maloney:

 

We are in receipt of your letter of October 5, 2004, which states that 3TP’s internet website ( www.3tp.net) [1] demonstrates that 3TP is marketing its software for intended uses that do not fall within its existing 510(k) clearance.

 

First, we would like to state that we do not intend to market any of our products for indications beyond the scope of our FDA clearance.  Further, in response to your letter 3TP LLC has taken the following actions.  We conducted an investigational review of the statements on our website to ensure that all references to the intended use of our software are within the indications of our 510(k) clearance. This review was made in accordance with our previously established 3TP Quality Assurance Manual.   All changes on our website necessary to conform to the statements of intended use in our FDA clearance have been implemented within the specified time period indicated in your letter.

 

To ensure that all future modifications to the website are within the appropriate parameters of the claims specified in our 510(k) clearance, a communication was sent to all relevant employees directing them to review the section of our 3TP Quality Assurance Manual that deals with design and approval of website materials.  Also, a copy of the FDA Warning Letter was circulated to employees involved with promotional materials to provide examples of statements that are not acceptable.

 

We believe these actions are sufficient to rectify the situation, put 3TP in a compliant position regarding our website, and ensure future compliance.

 

Sincerely,

/s/

Andreas Muehler

President

3TP LLC



 [1] You indicated our website to be http://vclassroom.hyperion.com however our website is http://www.3tp.net . Due to a technical error at the Hyperion website, this specific part of the Hyperion website points to our website. We are working with Hyperion to resolve this technical error but would like to point out that there is no business relationship whatsoever between 3TP LLC and Hyperion.