Products Liability Implications of the DIY Healthcare Environment

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Mark Senak recently published an insightful post over at Eye on FDA on “The Growing World of Do It Yourself Health.” In it, he remarks how the advent of certain products and technologies are accelerating the “DIY” movement in healthcare. Among the factors he points to as underlying this movement are “Dr. Google” and the overall ability of individuals to self-diagnose and learn about their conditions via the internet; direct-to-consumer advertising educating patients on conditions and treatment options; the massive supplement industry that allows consumers to self-prescribe a combination of non-drug products to treat or prevent specific maladies; social media facilitating crowd-sourcing and the sharing of symptoms and treatment solutions and experiences; and wearable devices and health apps that make available to users constant readings of health information like heart rate, activity levels, blood pressure, and sleep patterns. Being that the blog is Eye on the FDA, Mr. Senak’s focus is on the regulatory implications of these changes. He notes that the FDA has been rather slow in addressing the change that these factors have precipitated and are, perhaps understandably, struggling to keep up with this area of such dynamic change.

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FDA Issues Draft Guidance on General Wellness Products

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

On Friday, January 16, the Food and Drug Administration published two draft guidances pursuant to its FDASIA-mandated Health IT Report, released in April of last year: (1) General Wellness: Policy for Low Risk Devices; and (2) Medical Device Accessories: Defining Accessories and Classification Pathways for New Accessory Types. This post discusses the first.

General Wellness Products

The first draft guidance, General Wellness: Policy for Low Risk Devices, does very little in the way of policy. Rather, the majority of the Guidance is devoted to defining what general wellness products are and helping industry determine whether their devices fall under this policy. Continue reading “FDA Issues Draft Guidance on General Wellness Products”