On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” (the “Inspection Draft Guidance”), which clarifies the types of behaviors that FDA considers to be inappropriately delaying, denying, limiting, or refusing access to an inspection, each of which constitutes adulteration of a drug or device under the Federal Food, Drug, and Cosmetic Act (FDCA).[1] The Inspection Draft Guidance clarifies certain behaviors described in FDA’s previous guidance on the subject (the “2014 Guidance”) and, most significantly, expands the previous guidance to apply to medical device manufacturers.

Continue Reading FDA Expands Inspection Guidance to Apply to Device Manufacturers

The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. In Prometheus Group, the government alleges that the defendant medical device manufacturer trained providers to re-use disposable rectal probes against U.S. Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The complaint alleges that Prometheus put vulnerable Medicare patients at risk to gain a marketing advantage by reducing overhead costs associated with its systems. The message to medical device manufacturers is clear: even without submitting claims to the government themselves, manufacturers can face FCA liability for suggesting providers use their devices in any way the FDA has not approved (and in this case, warned against).

Continue Reading The Government Seeks FCA Liability for Off-Label Use of Medical Devices

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway.
Continue Reading FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence