Navigating Medical Device Regulation and IP Protection in the United States (Part 1 of 2)
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases overlapping with—the frameworks for drugs and biologics. Understanding these distinctions is critical for innovators and practitioners navigating Food and Drug Administration (FDA) oversight and the IP landscape in order to protect valuable investment and bring products to market.
Part one of this two-part series examines how FDA defines and classifies medical devices in the United States, distinguishing them from drugs and describing the regulatory pathways and risk-based classifications that govern their approval and marketing. Part two will examine the IP and exclusivity landscape for medical devices in the US.
Is the Product a “Drug” or a “Device?”
While both drugs and devices are statutorily defined as products “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body,” or “intended to affect the structure or any function of the body of [humans] or other animals,” a key distinction is that a device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,” “does not achieve its primary intended purposes through chemical action within the body” and “is not dependent upon being metabolized for the achievement of its primary intended purposes.”
These definitions create an inherent overlap—products that meet the definition of a device also meet the definition of a drug. So how are products that might meet either definition regulated? In practice, FDA exercises broad discretion in deciding whether to classify and regulate products as drugs or devices. Historically, FDA has been bullish on exercising its authority and discretion in this area, in part because Congress has not infrequently stepped in to codify FDA practice that has been challenged by industry in litigation. However, this discretion is not without limits—in recent years, courts have emphasized that FDA cannot arbitrarily expand the definition of a drug to encompass products that also meet the statutory device definition. Because the Federal Food, Drug, and Cosmetic Act (FDCA) defines “device” more narrowly than “drug,” where the definitions conflict, courts have held that the narrower definition controls.
FDA has since appeared to somewhat soften its stance, or at least focus more on the factors that the courts have highlighted as important in making classification decisions. These factors include:
- Mechanism of action, whether chemical or physical; and
- Intended use, based on manufacturer claims, marketing materials, or other evidence.
Differences in Device Classification for Marketing and Regulation
Medical devices are classified into three regulatory classes based on risk:
- Class I carries the lowest risk, and includes devices like elastic bandages, dental floss, and prescription eyeglasses;
- Class II devices carry moderate risks, and include products like syringes, motorized wheelchairs, and daily-wear contact lenses; and
- Class III devices are considered to be the riskiest, and include items like implantable pacemakers, infusion pumps, and extended-wear contact lenses.
While classification affects the level of FDA controls, certain baseline regulations called “General Controls” apply to all devices. These include rules to prevent adulteration and misbranding, registration and listing requirements, adherence to Good Manufacturing Practices, repair and replacement protocols, and recordkeeping. FDA can also ban or restrict devices at any level.
For higher-risk devices (generally Class II and III), additional regulatory requirements called “Special Controls” may apply, and may include performance standards, post-market surveillance, patient registries, labeling requirements, and mandatory testing protocols. Class II and Class III devices also have more stringent requirements that must be met before the product can be marketed:
- Class II devices generally require 510(k) clearance, which involves demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and performance testing.
- Class III devices require Premarket Approval (PMA), which requires demonstration of safety and effectiveness for the intended use, typically through clinical trials.
Certain exceptions may apply. For example, sponsors can pursue a De Novo Classification Request where no predicate device exists, but general controls (or general and special controls) provide reasonable assurance of safety and effectiveness for the intended use. Devices called Humanitarian Use Devices (HUDs)—which are intended to treat fewer than 8,000 people per year in the US—may qualify for a Humanitarian Device Exemption (HDE) if no comparable legally marketed alternative exists. HDE waives efficacy requirements that typically apply to Class III devices, provided the sponsor can demonstrate that probable benefits outweigh the risks. However, significant limitations apply to HUDs approved under an HDE—these devices generally cannot be sold for profit except in limited pediatric or specific adult-use scenarios, and sales cannot exceed an “annual distribution number” set by FDA.
In addition, FDA applies specialized requirements for in vitro diagnostics that are generally commensurate in scope with the associated risk (e.g., consideration of the clinical consequences of a false result, specimen handling, analytical and clinical validation requirements).
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