NeuroTrax Israel Ltd. 3/15/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
MAR 15 2012
VIA UNITED PARCEL SERVICE
Ely Simon, M.D.
Chief Executive Officer
Dear Dr. Simon:
The Food and Drug Administration (FDA) has learned that your firm is marketing the MindStreams Cognitive Health Assessment Software (MindStreams) in the United States (U.S.) without marketing clearance or approval. The Office of Compliance, in FDA’s Center for Devices and Radiological Health, reviewed your firm’s website at www.neurotrax.com for MindStreams and determined that, under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (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 function of the body. As such, your firm’s marketing of this device in the U.S. without premarket clearance or approval is a violation of the Act.
The MindStreams device is a class III device under section 513(f) of the Act, 21 U.S.C. § 360c(f). The device is 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 under Section 520(g) of the Act, 21 U.S.C. § 360j(g). For a device requiring premarket approval, the notification required by Section 510(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 devices is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html
. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.
FDA received your firm’s 510(k) premarket notification (b)(4) for the MindStreams device on March 9, 2007. Subsequently, FDA determined that the device is “Not Substantially Equivalent” to devices marketed in interstate commerce prior to May 28, 1976, or to any device that has been reclassified into class I (General Controls) or class II (Special Controls), or to another device found to be substantially equivalent through the 510(k) process. FDA issued a letter to your firm, dated December 21, 2007, indicating that the performance data did not demonstrate that the device was as safe and effective as legally-marketed devices. The correspondence explained that the device is thereby classified by statute into class III (Premarket Approval), under Section 513(f) of the Act. FDA also indicated in that letter that any commercial distribution of this device prior to approval of a PMA, or the effective date of any order of the FDA reclassifying this device into class I or class II, would be a violation of the Act. Your firm issued a letter of appeal, dated April 10, 2008. On December 4, 2008, FDA responded with a letter concurring with the earlier finding of “Not Substantially Equivalent” based on lack of performance data.
Your firm should take prompt action to correct the violation addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. U.S. 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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please submit a written response to this letter within 15 working days from the date your firm receives this letter, describing your firm’s intent to comply with this request, listing all promotional materials for MindStreams and explaining the specific steps that your firm has taken or plans to take for discontinuing use of such materials and otherwise ceasing the marketing of this product for use as a device without premarket approval. If cessation of such promotion and marketing cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please direct your firm’s response to CDRH. Charles Cathlin Jr. at the Food and Drug Administration, 10903 New Hampshire Avenue, WO66-2648, Silver Spring, MD 20993, or via facsimile to (301)847-8128. FDA reminds your firm that only written communications are considered official.
The violation discussed in this letter does not necessarily constitute an exhaustive list. It is your firm’s responsibility to ensure that its promotional materials for MindStreams comply with each applicable requirement of the Act and FDA implementing regulations.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health