Medical devices are classified under federal law as those products that are “. . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals . . .” and “which [do] not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” 21 U.S.C. § 321(h). While the FDA explains that the Company’s initial response notes it “did not intend for any of its products to be used in the treatment, cure, mitigation, prevention or diagnosis of any disease,” thus rendering its product outside of the purview of the medical device definition, the FDA reaffirms its stance that the statements made in the Company’s marketing, including its website, cause the product to be considered a medical device. Because products are regulated based on their intended use, it is important to understand the effect that marketing alone may have on the way a product is regulated. More information about the FDA’s regulation of medical devices may be accessed at our previous post, found here.

In addition to understanding how the FDA regulates medical devices, it is critical to understand the FDA’s various enforcement mechanisms, both informal and formal. In particular, warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Under the terms of a warning letter, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. Firms must respond to all violations, including those not explicitly cited by the Agency, or they may be subject to further agency action, including formal enforcement measures. Because appropriate corrective measures may often preclude further enforcement measures, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance and doing so may help a company remain in business without further issue. For more information about establishing or maintaining compliance with the regulations or laws FDA enforces, please contact us at contact@sglawfl.com.

The approval of an at-home HIV test kit marks a milestone with respect to HIV testing. Before today, the FDA has only approved HIV tests to be used by trained practitioners in medical settings. In fact, OraSure Technologies, Inc., the manufacturer of the OraQuick In-Home HIV Test, was first approved in 2004 for use in clinical settings by trained professionals. Devices associated with blood donor testing, like the one FDA test kit here, must secure FDA authorization through the Premarket Approval (“PMA”) process. Through this process, the FDA approves products for only those specific conditions and/or uses listed in the product labeling. Thus, while similar tests have been available on the market, this is the first time these tests may be marketed and sold to the public for use in the home.

For more information about the PMA process or other regulatory issues, please feel contact us here.