MaRS Library Step 1: Classify your healthcare product
Healthcare product development is complex. It is critical to know the general product development lifecycle so that you can follow the correct path. Knowing which pitfalls to avoid will speed your time to market. This article outlines step 1 of the 10 steps to develop a healthcare product.
When developing a healthcare product, the first question to ask is, “is my product regulated?” If the answer is yes, the next question to address is, “how is my product classified?”
Different types of products are regulated under different regulations. By knowing the correct product classification, you can identify the right path to have your product reach your target market. The four major groups of products are definedi below:
- Drug: A substance which exerts an action on the structure or function of the body by chemical action or metabolism. For example, a drug is defined in the US as “(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).”1
- Biological product: Generally,a biological product is of a substance derived from or made with the aid of living organisms. It is defined in the US as “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.”2
- Medical device: A medical device is defined in the US asan “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) 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 (3) 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.”3 This may include products such as software designed to aid in the diagnosis of a certain condition.
- Combination product:iiA combination product is one which has two components in different regulatory categories (for example, drug/device, biologic/device, drug/biologic, or drug/device/biologic); these two components are physically, chemically or otherwise combined or mixed and produced as a single entity.4
The classification for most healthcare products may be obvious, but this may not be the case for combination products.5 Thorough evaluation is needed to identify how these products are regulated. Although all components (for example, both drug and device) are subject to regulatory review to support the quality, safety and efficacy, identifying the classification for a combination product will determine the regulatory pathway for your product―that is, the submission type required (for example, a Premarket Approval [PMA]or a New Drug Application [NDA]) and the review division that will lead the review of your application.
Identify the classification of your healthcare product
When identifying the classification of your healthcare product, the key questions to address are:
- What is my product intended to do?
- Through what means can the intended use be primarily achieved?
To answer the first question, you need to identify the claim or the intended use. Is it to diagnosis, cure, mitigate, treat or prevent a certain disease or condition? The next step will be to identify the “primary mode of action” (PMOA) for your product to achieve such a result.5
The examples in the table below illustrate how the intended use and PMOA can affect product classification. They are based on combination products approved or cleared by the U.S. Food and Drug Administration (FDA).6
In example 1, a skin transdermal patch containing a drug [substance X] that activates receptors in the body (the PMOA) is classified as a drug. Similarly, in example 2, the inhaler is a device designed to deliver a drug [substance Y] to treat [condition 2]. As the PMOA is through [substance Y], it is classified as a drug.
In examples 3 and 4, although antimicrobial/antibiotic agents are used to prevent microbial adhesion on the devices, the PMOA is achieved through the implant or physical covering of a wound that does not exert via a chemical action or by being metabolized. Thus these products are classified as devices.
The decision tree below outlines the key steps in identifying the classification of a combination product.
Combination products: Examples
Primary mode of action (PMOA)
Other mode of action
|Skin transdermal patch containing a backing, an adhesive drug, [substance X], and a release liner||Substance X||Transdermal patch||Patch works by delivering [substance X] through the skin and into the bloodstream to treat [condition 1]. [Substance X] is an agonist that works by activating receptors in the body||Substance X activates the receptors||Patch as a delivery tool||Drug|
|Inhaler with [substance Y]||Substance Y||Inhaler||Inhaler that delivers [substance Y] to treat [condition 2]||[Substance Y] to treat [condition 2], whereas inhaler is only a delivery tool||Inhaler as a delivery tool||Drug|
|Surgical mesh with antibiotic coating||Antibiotic in coating||Mesh||Implant intended to treat [condition 3]||Implant||Antibiotic acts as an ancillary function||Device|
|Wound dressing containing antimicrobial agent||Anti-microbial agent||Wound dressing||Dressing is intended to absorb exudates and cover a wound||Wound covering||Antimicrobial acts as an ancillary function||Device|
Confirm the classification with the regulatory agency
Once the healthcare product classification for a combination product has been identified, the developer should confirm the classification with the relevant regulatory agency (or agencies). This should be done at the start of the product development lifecycle (drugs and medical devices) as this determination will impact the regulatory pathway required and the studies needed to support product approval.
Decision tree for classifying combination products
i Definitions based on US regulations. Wording used by different jurisdictions (Canada, US and EU) may vary, but the general principles remain the same.
ii Other types of combination products are listed in 21 CFR 3.2(e).7
Read the next step in the 10 steps on healthcare product development: Step 2: Identify your healthcare claim and product label
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012
- United States Code. (2011). Title 21, Section 321, Definitions; generally. Subsection (g)(1). Retrieved August, 15, 2012, from http://www.gpo.gov/fdsys/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap9-subchapII-sec321.htm.
- United States Code. (2011). Title 42, Section 262, Regulations of biological products. Retrieved August 15, 2012, from http://www.gpo.gov/fdsys/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap6A-subchapII.htm.
- United States Code. (2011). Title 21, Section 321, Definitions; generally. Subsection (h). Retrieved August 15, 2012, from http://www.gpo.gov/fdsys/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap9-subchapII-sec321.htm.
- U.S. Food and Drug Administration. Combination product definition. Retrieved September 21, 2012, from http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm118332.htm
- Tobin, J.J. & Walsh, G. (2008). Chapter 1. The aims and structure of regulations. Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA.
- U.S. Food and Drug Administration (2011, December). Examples of combination product approvals. Retrieved September 21, 2012, from http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm101598.htm.
- United States Code. (2012). Title 21, Section 3.2(e). Combination products. Retrieved September 21, 2012, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=3.2.