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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Neomedix Corp 2/26/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire A venue
Silver Spring, MD 20993 

FEB 26, 2014

WARNING LETTER
 
Via United Parcel Service
 
Dr. Michael Mittelstein
President
NeoMedix Corporation
15042 Parkway Loop
Suite A
Tustin, California 92780-6528
 
Re:  Trabectome High Frequency Generator/LP
        K061258
 
Refer to CPT1400130
 
Dear Dr. Mittelstein:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Trabectome High Frequency Generator/LP (Trabectome) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is 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 Trabectome was cleared under K061258 for “use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.” The K061258 submission did not include data regarding the treatment of glaucoma, and the device was not cleared for the treatment of glaucoma.  FDA has reviewed your website (www.neomedix.net, most recently on February 25, 2014), including the invite/agenda for an external training on the Trabectome to be given on February 27, 2014, in Washington, DC, available at http://www.trabectome.com/Learning/TrabectomeTraining/Register.  These materials provide evidence of a major change or modification in the intended use of your device under 21 CFR § 807.81(a)(3)(ii). For example, these materials promote the Trabectome for the “minimally invasive surgical management of glaucoma,” “for minimally invasive treatment of glaucoma,” and “33% IOP [intraocular pressure] Reduction on Average.” 
 
Therefore, the Trabectomeis adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the device as described and marketed.  The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). 
 
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency.  21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.  The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Our office requests that NeoMedix Corporation immediately cease activities that result in the misbranding or adulteration of the Trabectome, such as the commercial distribution of the device for the uses discussed above.
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
 
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your firm’s response should be sent to:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number CPT1400130 when replying. We remind you that only written communication is considered as official.  If you have any questions about the contents of this letter, please contact: Mrs. Debra E. Demeritt at 301-796-5770 or by facsimile at
301-847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA. 
 
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
     Radiological Health