Warning Letter – Software controlled product has not been registered with FDA

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, TALON, an S&S Technology Company, located in Houston, TX, from March 11 – 28, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer of various Class I & II medical equipment, healthcare supplies, and radiation products used for general and plastic surgery. 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.

This inspection revealed your devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response dated April 24, 2019 from your Quality Assurance Manager which responded to the Form FDA 483, Inspectional Observations issued to your firm on March 28, 2019. We address your response below, in relation to each of the noted observations. These violations include, but are not limited to, the following:

Medical Device Listing

Further, we also note the FDA investigator observed that you manufacture software-controlled medication cabinets and carts used for security and convenient access to medications and medical supplies, accounting for (b)(4)% of your business. Review of your Talon Med.Key and Med.Key Lite software literatures indicated that the Med.Key Lite software is available on Anesthesia Carts which are Class I Exempt devices, under 21 CFR 868.6100, Product Code BRY. Based on this information, you should register and list this software under the appropriate regulation.

Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual device listing requirements of the MedKey Lite software for fiscal year 2019.

Additionally, your software literature asserts as part of MedKey Lite benefits that the software has been FDA approved. Upon review of FDA’s registration and listings database and premarket notification 510(k) database, we were not able to locate any premarket submissions associated with this product. If the device was exempt from premarket notification, we were not able to locate any information to demonstrate that your firm has listed your MedKey Lite software with the Agency. Therefore, FDA does not agree that the manufacturer can promote FDA approval statements on the firm’s website and/or product literatures unless they are able to provide the appropriate application for which approval was received.

A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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