The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” This document provides information on how the FDA evaluates uncertainty and the appropriate extent of uncertainty in the benefit-risk determination for medical devices that are subject to premarket approval (PMA).
Category: Regulatory
The FDA Is in the Doghouse
An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019).
There have been numerous reports of lawsuits involving allegedly contaminated pet food filed against pet food manufacturers or distributors by pet owners claiming that they were deceived by pet food labels and suffered harm either as a result of paying a premium for the food or because their pets were sickened by the food. In contrast, on July 5, 2019, a raw pet food company, Lystn, LLC, brought a civil action against the FDA seeking declaratory and injunctive relief. The complaint challenges the FDA’s ability to enforce what Lystn characterizes as “a nationwide zero-tolerance standard for Salmonella presence in pet food that is unsupported by science and ultra vires of powers properly delegated to it by Congress.”
FDA Final Guidance Document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry”
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information regarding “changes to approved risk evaluation and mitigation strategies (REMS),” the application process for proposed changes to REMS, and “how the FDA will process submissions.”
Not every pharmaceutical product approved by the FDA requires a REMS. “A REMS is a required risk management plan that uses tools beyond the prescribing information (the package insert) to ensure that the benefits of certain drugs outweigh their risks.” Following a REMS submission, an application holder might be inclined to submit proposed changes, or the FDA might require the submission of proposed changes. Application holders who find themselves in either position may turn to this final guidance document for direction.
Products in a New Dimension: Manufacturing Considerations for 3D-Printed Products
Since its advent more than 30 years ago, the 3D printing market has grown, and will continue to expand for a myriad of reasons, including sustainability and reduced energy consumption. As the process, including the applicable technology, becomes more cost-effective, its widespread use continues to increase across many industries, such as aerospace and defense, energy, architecture and construction, automotive, food/culinary, consumer products and health care.
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The CPSC Releases Framework of Safety for the Internet of Things
The rapidly developing technology of interconnected software allows consumers to reach new heights of convenience and efficiency. We can start our dinner remotely, listen to our music in every room in the house, track and log our heart rate and step count, and program our coffeepot to be ready for us in the morning. This technology sometimes is called the Internet of Things (IoT), which describes the interconnectedness of devices via the internet. These devices can exchange data between themselves to coordinate a variety of helpful functions. While this technology is exciting and signifies many positive new directions for consumer products, manufacturers should be aware of the potential risks that come with creating such products.
To that end, the U.S. Consumer Product Safety Commission (CPSC) released a Framework of Safety for the IoT (the CPSC Framework) in January 2019. The CPSC Framework provides “technology-neutral best practices to ensure consumer product safety” and to prevent “death, physical injury or illness” resulting from the use of IoT products. It is not intended to address privacy or confidentiality. While general in tone, the CPSC Framework is intended to assist with an “active approach” to safety rather than a reactive one in this quickly growing industry.
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Biometric Data Privacy: Why Illinois Regulation Is Relevant to Manufacturers Nationwide
Our federal system and the often dysfunctional nature of Congress can be vexing for cutting-edge manufacturers. Emerging technologies are rarely addressed at the federal level, leaving states to pass piecemeal regulations that can frustrate even the most attentive compliance officers. If you’re bringing a product to market nationwide, you need to be aware of which states have the most stringent regulations. When it comes to biometrics, Illinois tops that list.
The Illinois Biometric Information Protection Act (BIPA) generally is considered the most stringent in the United States, and lawmakers in Florida and New York City are currently working on passing similar measures. So just what is the current state of biometric data privacy in Illinois? The answer lies in three rather unexpected topics: roller coasters, robot dogs, and pizza.