Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm547175.htm
Timestamp: 2019-01-23 04:57:25
Document Index: 388165377

Matched Legal Cases: ['§ 321', '§ 360', '§ 807', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360', '§ 807', '§ 807']

Ark Bio Medical Canada Corp 3/7/17
CBER-17-03
UPS EXPRESS MAIL
Mr. Wendell E. Dawson
ARKBio-Medical Canada Corp.
671 Russtico Road
North Milton, Prince Edward Island
Canada C1E 0X5
Dear Mr. Dawson:
During an inspection of your firm located at 671 Russtico Road, Route #7, North Milton, Prince Edward Island, Canada, between July 14 and July 17, 2015, an investigator from the United States Food and Drug Administration (FDA) documented that your firm manufactures the ARK Bio Microwave Plasma Defroster. 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 any function of the body.
FDA has reviewed the documents collected during the July 2015 inspection and additional information you and your firm (collectively, “you”) submitted to FDA in August, November, and December 2016, in response to an Untitled Letter FDA issued to you on November 18, 2015. The agency’s review of this material reveals that you are marketing the ARK Bio Microwave Plasma Defroster without FDA marketing clearance or approval, in violation of the Act.
The currently marketed ARK Bio Microwave Plasma Defroster differs from the originally cleared device, WestLabs Model 601 Blood Plasma Warming Device (BK 870009). For example, your replacement of the device’s obsolete 8-bit chip with a new (b)(4) requires, at minimum, a change to a Printed Circuit Board to handle additional pins, re-implementation of code (most likely in C language), and voltage and power management for the new chip. Additionally, the currently marketed ARK Bio Microwave Plasma Defroster has new features that the original device lacked, including features that enable the device to handle larger bag holders and that provide alarms (i.e., lights that flash when the plasma reaches a certain temperature). Because these and other changes or modifications to the device could significantly affect its safety or effectiveness, FDA regulations require you to submit a new premarket notification to FDA for the ARK Bio Microwave Plasma Defroster pursuant to section 510(k) of the Act, 21 U.S.C. § 360(k). See 21 C.F.R. § 807.81(a).
The ARK Bio Microwave Plasma Defroster is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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 the device as marketed. The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). See also 21 C.F.R. § 807.81(a)(3). 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 C.F.R. § 807.81(b). The kind of information that you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.
Neither this letter, the Untitled Letter, nor the observations listed on the Form FDA 483 presented at the conclusion of the July 2015 inspection is intended to be an all-inclusive list of deviations that may exist at your facility. It is your responsibility to ensure that you are in compliance with the Act and all applicable U.S. laws and regulations.
Please notify this office in writing, within 15 working days of receipt of this letter, of any steps you have taken or will take to correct the violations noted in this letter. Include all documentation necessary to show that corrective action has been achieved. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the correction will be completed. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Silver Spring, MD 20993-0002.