Medical Device Classifications
Determination of the most likely regulatory path for a specific medical technology is an important early step toward commercialization. Regulatory requirements can greatly affect the overall development cost as well as the timing of market introduction. The regulatory path, along with the prospects for Medical Device Reimbursement, may even affect your decision regarding which country you target for first market launch.
Is your product a “medical device”, as defined by the U.S. Food and Drug Administration?
In the U.S., medical technology can be classified as a drug, device, biologic or a combination of these. The first step in determining whether or not a health-related device would be regulated by the FDA is to see if it meets the definition of a “medical device” under FDA regulations.
Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act defines a medical device as:
“A product will be regulated by the FDA as a medical device, and is subject to pre-marketing and post-marketing regulatory controls if it is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- Recognized in the official National Formulary, or the United States Pharmacopoeia, 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 any of 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 any of its primary intended purposes.”
If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually classified as a “drug product”. In general, if the product contains or utilizes biological materials such as a virus, toxin, antitoxin, vaccine, blood components or proteins, and will be applied to the prevention, treatment, or cure of a disease of human beings, it will be classified as a “biologic product”.
Some products will be a combination of a drug, device and/or a biologic. These “combination products” are handled under intercenter agreements between the FDA Centers for Devices and Radiologic Health (CDRH), Drug Evaluation (CDER), and Biologics Evaluation (CBER). For more information, see section Combination Product Approval.
In which FDA Device Classification does your product belong?
The U.S. FDA classifies medical devices based on the safety risks associated with the device. Devices are classified into one of three categories: Class I, II, or III.
- Class I
Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls, most often resulting in an exemption from the 510(k) Pre-Market Notification process. There are, however, other requirements referred to as “General Controls” that apply to all medical devices. Among those provisions are requirements for device registration, proper branding, and compliance with design controls and Good Manufacturing Practices (GMP). For more details visit this FDA site regarding General Controls.
- Class II
Class II devices are moderate risk devices and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. Class II devices must comply with the General Controls, but are also regulated by the 510(k) Pre-Market Notification process. For more information on this regulatory process, see 510(k) Pre-market Notification Process.
- Class III
Class III devicesare generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must be approved by FDA through the Pre-Market Approval (PMA) process. For more information on this regulatory process, see Pre-Market Approval (PMA) Process.
The following table includes additional product examples within each category of risk.
|FDA Medical Device Classification||I||II||III|
|Patient Risk Category||LOW||MODERATE||HIGH|
|Product Examples||Otoscope,Exam Gloves||In vitro Diagnostics, Patient Monitors||Cardiac Pacemakers, Heart Valves|
|Route of “Clearance” / Approval to Market||Potential Exemption from 510(k)||510(k) Pre-Market Notification||Pre-Market Approval (PMA)|
If you would like information regarding a particular marketed product’s FDA classification, or to get insight on the prospective classification of your product concept, follow this link to the FDA Product Classification database.
Medical Specialty Panels
FDA has classified and described over 1,700 distinct types of devices and organized them within the Code of Federal Regulations (CFR) into 16 medical specialty “panels”. These panels are found in Parts 862 through 892 in the CFR and a listing can be found at the following FDA website. For each of the devices classified by the FDA, the CFR gives a general description including the intended use, the safety class to which the device belongs, and information about marketing requirements.
Which FDA approval path is appropriate for your product?
For guidance in this determination, go to Medical Device Approval Requirements.
What is the insurance reimbursement status for products in your category?
For information related to the structure of the U.S. healthcare payment system, and for specific information related to insurance reimbursement planning, visit Medical Cost Reimbursement