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

Public Health Service
Food and Drug Administration
 
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087

Telephone:      303-236-3000        

FAX:        303-236-3551 

 

May 8, 2015
 
WARNING LETTER
                       
                                   
Vaughn R. Cook, CEO
ZYTO Technologies, Inc.
387 South 520 West, Suite 200
Lindon, UT 84042
 
VIA UPS
 
Ref # DEN-15-10 WL
 
Dear Mr. Cook:
 
During an inspection of your firm located at 387 South 520 West, Suite 200, Lindon, Utah, on November 14, 2014 through December 3, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ZYTO Hand Cradle, a Class II galvanic skin response measurement device, and the ZYTO Laser and ZYTO Tower, which are intended to be used as accessories with the ZYTO Hand Cradle. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body of man or other animals.
 
During the inspection, we observed your firm’s manufacturing and distribution activities pertaining to the ZYTO Hand Cradle galvanic skin response device. We also collected labels, labeling, and promotional materials for the ZYTO Hand Cradle and supporting accessories. This inspection concluded on December 3, 2014 with the issuance of an eleven item FDA Form 483, Inspectional Observations.
 
We acknowledge receipt of your firm’s letter dated December 22, 2014, responding to the FDA Form 483. We have determined that your firm’s response was inadequate in failing to address the concerns discussed with your firm during the inspection pertaining to your firm’s labeling and promotion of its products.
 
The FDA has reviewed pertinent information obtained during the inspection and reviewed your company’s website. We have determined that the ZYTO Hand Cradle 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the device as described and marketed. The ZYTO Hand Cradle is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered 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). 
 
Specifically, the ZYTO Hand Cradle was cleared under K111308 with the following intended use: “the measurement of galvanic skin response (GSR).” However, your firm’s promotion of the device represents a major change or modification to its intended use, for which your firm lacks clearance or approval. Examples include:
 
 
The promotion of the ZYTO Hand Cradle for use in diagnosing a disease or condition, predicting biological responses to a wide range of virtual stimuli including drugs and nutritional supplements, or determining whether someone responds to a specific allergen fall outside of the device’s cleared intended use to measure galvanic skin response and constitutes a major change or modification to the device’s intended use.
 
In addition, based on FDA’s review of the materials obtained during the inspection, we have determined that your firm is distributing the ZYTO Laser and ZYTO Tower without marketing clearance or approval. The ZYTO Laser and ZYTO Tower are intended to be used with the ZYTO Hand Cradle for the transmission, interpretation, and creation of virtual stimuli items (VSI). These VSIs are then added to the user’s library for “bio-communication” when using the ZYTO Hand Cradle.  The ZYTO Laser and ZYTO Towerare adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved PMAs in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for IDEs under section 520(g) of the Act, 21 U.S.C. § 360j(g). The ZYTO Laser and ZYTO Tower are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these devices into commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k). 
 
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 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 your firm submits and decide whether your products may be legally marketed.
 
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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 (including any systemic corrective actions) that 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 15 working 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, Denver District, P.O. Box 25087, (6th Ave. and Kipling Pkwy., DFC, Bldg 20), Denver, CO 80225-0087, Attention: Matthew R. Dionne, Pharm.D., Compliance Officer. Refer to the identification number DEN-15-10 WL 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 Dr. Dionne at (303) 236-3064.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your firm. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA Form 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s marketing and distribution practices. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring the products into compliance.
 
Sincerely,
/S/ 
LaTonya M. Mitchell
District Director

This page was posted on May 21, 2015.

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