April 1, 2013 -- The U.S. Food and Drug Administration (FDA) has learned that your firm is marketing the SIGMA Spectrum Infusion Pump with Master Drug Library. 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.
On September 13, 2012, the Office of Device Evaluation notified your firm’s management, in writing, that your firm’s (b)(4) for the SIGMA Spectrum Infusion Pump with Master Drug Library (b)(4). Your firm was advised in a September 27, 2012, teleconference with the Office of Compliance that if your firm (b)(4). Based on email correspondence between your firm’s management and the Office of Compliance on December 21, 2012, your firm (b)(4).
Therefore, the device is adulterated under section 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The SIGMA Spectrum Infusion Pump with Master Drug Library is also misbranded under section 502(o) 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 in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 C.F.R. 807.81(a)(3)(i).
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 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Please submit a written response to this letter, referencing CMS case #325699, within fifteen working days from the date you receive this letter, describing specific steps your firm will take 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. Please direct your response to Carl Fischer, Ph.D., at the Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 3526, Silver Spring, Maryland 20993, facsimile at 301-847-8137. We remind you that only written communications are considered official.
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.
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. 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.