The medical device industry seems to be a limitless pathway of innovation, creativity, and advancements. However, navigating this pathway can be a challenge, and as increasingly complex and combination products enter the arena, more guidance is required to steer the way.
In response to multifaceted products which may combine devices, drugs, and biologics, the FDA has released “Guidance for Industry and FDA Staff: Interpretation of the Term ‘Chemical Action’ in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.”
The term “device” is defined in the FD&C Act as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
- recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
In short, what does this mean? Under this definition a product is not a device if it achieves its intended purposes through a chemical action within, or on, the body.
So, how does the FDA define a “chemical action”? They take a very broad approach by stating that through either chemical reaction, or intermolecular forces (or both) the product:
- medicates a bodily response at the cellular level, or
- combines with, or modifies an entity so as to alter that entity’s interaction with the body of man or other animals.
So this means that if an investigational product fits the above description, it is not a device? Does this proposed interpretation open the door for the FDA to consider any device that changes the state of a cellular molecule a drug? Does this seem subjective ?
IMARC is a proud member of LifeScience Alley™ who hosted an event titled “Interpreting ‘Chemical Action’ - Can the Proposed FDA Guidelines Be Interpreted to Avoid Having Some Medical Devices Designated as Drugs?”
MedCity News also covered this issue in a recent article. The article references Keith Hildebrand, senior principle scientist at Medtronic and who spoke at the LifeScience Ally™ program. He believes the issue is complicated because the FDA is trying to draw a specific line in the sand, but it’s like drawing a line on a continuum. One definite point he makes is that “if the product requires metabolism by the body to become active, then the product is not just a device.”
We look forward to the discussion and feedback this guidance will generate. What are your thoughts on this industry issue?