Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have occurred within traditional manufacturing facilities. Over the past two years, however, supply chain disruption caused by the COVID-19 pandemic has created medical device shortages that have amplified the use of 3D printing technologies at the point of care. Indeed, healthcare providers have collaborated with 3D printing companies to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts within healthcare facilities. As 3D printing technologies improve and healthcare facilities innovate in the face of economic opportunities and pandemic-related challenges, the industry can expect increasing use of 3D printers within the healthcare setting. In turn, FDA is taking notice and has recently issued a paper to facilitate discussion about potential approaches to regulating 3D printed devices at the point of care.
Category: Regulatory
Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts
Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care clinics for minor illnesses or simple-to-prescribe medications. The last two years shifted that race into high gear, particularly with new products and platforms being introduced that range from virtual clinic platforms that allow patients—and their programmable implanted medical devices—to connect with their providers from the comfort of their own homes, to passive smart devices that remotely monitor patient vital signs, analyze that data using proprietary algorithms, and evaluate whether a patient is having a medical emergency or needs to schedule an appointment with their provider. These technologies are now so ubiquitous that they are being showcased at the 2022 Consumer Electronics Show.
To be sure, regulatory changes in response to the COVID-19 pandemic made telemedicine more permissible—and reimbursable—than in the past. But that alone is not driving medical device companies forward. Instead, medical device manufacturers are rapidly developing smart or algorithm-driven medical devices that take advantage of the ever-increasing power of those technologies and leveraging telemedicine to make the remote treatment and management of medical conditions less complicated. A recent article in Nature’s npj Digital Medicine confirmed the growth in this area, counting 64 separate smart- or algorithm-driven medical devices currently on the market as of 2020. See Stan Benjamens, et al., The State of Artificial Intelligence-Based FDA-Approved Medical Devices and Algorithms: An Online Database, 3 npj Digital Medicine Article No. 118 (2020). Each of these new devices endeavor to enable physicians to practice more effectively and efficiently than they could before. The future for smart or algorithm-driven medical devices looks promising.
Circuits Split on CMS Vaccine Mandate, Highlighting “Great Significance” of Issue as It Heads to Supreme Court
Three circuit court decisions issued in the past two weeks have considered the CMS vaccine mandate, bringing the issue – and similar vaccine mandate lawsuits – to the Supreme Court in the final weeks of the year. The CMS mandate generally requires that facilities certified to participate in Medicare or Medicaid ensure their staff are fully vaccinated against COVID unless the employee is exempt for medical or religious reasons. CMS issued the vaccine mandate on November 5, 2021. It went into effect immediately, with staff to be fully vaccinated by January 4, 2022.
FDA Issues Draft Guidance for Sponsors and Other Stakeholders on Using Registries as RWD to Support Regulatory Decision-Making
The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drugs and Biological Products, the FDA discusses considerations for sponsors and other stakeholders when designing or using an existing registry as RWD to support a regulatory decision about the safety and effectiveness of a medicine or biologic.
The goal of the RWE program, in part, is to satisfy Congress’s mandate under section 505F of the Federal Food Drug and Cosmetic Act (FD&C Act) for the FDA to provide more guidance about the use of RWE in regulatory decision-making. We discussed the FDA’s first and second guidances, released in August and October 2021, here and here.
How the Anti-Drunk Driving Technology Mandated by Recent Legislation May Impact the Liability of Automobile Manufacturers and the Future of Products Liability Law for Autonomous Vehicles
The Infrastructure Investment and Jobs Act (the “Act”), signed into law on November 15, 2021, has been followed closely by the transportation sector. One section of the Act has the potential to impact the landscape of automotive products liability litigation.
Section 24220 requires automobile manufacturers to equip new passenger vehicles with advanced drunk and impaired driving prevention technology. Infrastructure Investment and Jobs Act, Pub. L. No. 117-58, § 24220, 135 Stat. 429, 831-833 (2021).
FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data
The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts on how sponsors can comply with the Federal Food, Drug and Cosmetic Act (FDCA) when submitting “certain” applications that contain study data derived from real-world data (RWD) sources. The FDA acknowledges that its current study data standards do not necessarily reflect a process derived from RWD sources. However, sponsors will need to convert RWD into established study data standards when submitting this information as part of a regulatory application (a process called “mapping”).
For context, study data standards are documented guidelines to help with the exchange of clinical and nonclinical study data between computer systems. They are used to provide a consistent framework for organizing study data (such as templates for datasets, standard names for variables, how to do calculations with common variables, and so on).