September 10, 2018
McGuireWoods healthcare partner Kate Hardey and associate Timothy Loveland wrote an article published in the August edition of Bender’s Health Care Law Monthly exploring the Food and Drug Administration’s draft guidance on multiple function medical devices.
In response to the growing complexity of technology in medical devices, the FDA recently reworked its approach of regulating the “whole device” to looking at the constituent parts and functions of a device and the understanding the interplay between them. In their article, Hardey and Loveland discussed the draft guidance’s impact on multiple function device manufacturers and investors and explore the challenges and opportunities the new policy may present.
“While only in draft form, the Draft Guidance sets forth the agency’s current thinking,” the authors noted. “The guidance is relevant to all products that contain multiple functions regardless of whether they are software or hardware, and thus it may impact a wide range of manufacturers, including component and other contract manufacturers, as well as those involved in the assembly, servicing, or other function of a regulated device.”
They added, “Analyzing potential pitfalls under this guidance and preparing to meet future regulatory requirements are the responsibilities of the company involved with the device and should be fully understood by investors before making any investment in a regulated device.”
Their article, “FDA Guidance on Multiple Function Medical Devices: Pre-Market Considerations for Manufacturers and Investors,” is available online to subscribers.