Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Via United Parcel Service
September 11, 2013
John Howison Schroeder
Neuro Kinetics, Inc.
128 Gamma Drive
Pittsburgh, PA 15238-2920
Dear Mr. Schroeder:
During an inspection of your firm located in Pittsburgh, Pennsylvania on May 13, 2013, through May 17, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the I-Portal® Neuro Otologic Test Center (NOTC), the I-Portal® 4D Video Oculography System (VOG), and the I-Portal® Video Nystagmography System (VNG). 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 to affect the structure or any function of the body.
Our inspection revealed that the I-Portal® Neuro Otologic Test Center (NOTC), 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). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). Specifically, your firm failed to notify the agency that you intended to introduce into interstate commerce the (b)(4) CDs that your firm distributes with the I-Portal Neuro Otologic Test Center (NOTC). As cleared in K083603, this device should provide its output to a clinician for his/her determination of the clinical significance of the data. With a normative database, the device is providing its interpretation of whether the data it captured are representative of a normal range.
Providing normative data, in any form (e.g., installed on your device, on a CD, for download over the internet), for use with your device is a significant change to the technological characteristics of the device that requires submission of a new marketing application. 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 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.
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 (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 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.
Additionally, we request that you contact the FDA to set up a regulatory meeting to discuss violations set forth in this Warning Letter.
Your firm’s response should be sent to: Kirk D. Sooter, District Director, Room 901 U.S. Customhouse, Philadelphia, Pennsylvania, 19106-2973. If you have any questions about the content of this letter please contact: Richard C. Cherry, Compliance Officer, at (215) 717-3075 (phone) or Richard.Cherry@FDA.HHS.GOV.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. 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 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Kirk D. Sooter