Introduction
Working with many startups and businesses venturing into the medical device market, it has become common knowledge that the term 'medical device' is confused. The majority believes that a medical device must possess some mechanical components, and others quickly dismiss the fact their device is classed and regulated. This paper is intended to clear the murkiness that these misconceptions introduce. The goal being to reduce the time taken by contract manufacturing organizations such as Light Fabrications, Inc. in convincing startup businesses and individual inventors on what is a medical device and its class as my may be applicable according to the provisions of the United States Food and Drug Administration (FDA).

The Food and Drug Administration (FDA) regulate the distribution of medical device. Title 21 of the Code of Federal Regulation s (CFR) contains articles articulating the procedures and standards governing Current Good Manufacturing Practices (cGMP) of medical devices.

About 1,700 devices, grouped into 16 medical specialties or panels are classified into three broad categories. The description of each panel is contained in Title 21 CFR, Parts 862‐892, and each class is defined by regulatory controls imposed by the FDA to ensure the safety and effectiveness of the device. Let us understand what is a medical device is before delving into its classification.

What is a medical device?
The Food and Drug Administration (FDA), defines medical device as:
"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." (FDA, 2011)

Medical device controls and classification
All three classes are subject to general controls and some special controls. Controls are
procedures, and or processes that manufacturers and distributors of medical device MUST implement, unless in cases where exemption status prevail. FDA specified General Controls and Special Controls are:
General Controls
• Adulteration / Misbranding
• Electronic Establishment Registration
• Electronic Device Listing
• Premarket Notification [510(k)]
• Quality Systems
• Labeling
• Medical Device Reporting (MDR)
Special Controls
• Guidelines
• Mandatory Performance Standard
• Recommendations or Other Actions
• Special Labeling

The three classes are:

1. Class I
Subject to General Controls with and without exemptions
This is the class with the lowest risk devices; containing mostly non‐invasive devices. .
Examples include most types of bandage - elastic, liquid, cast, absorbent etc., hydrogel
wood dressing, stethoscopes, hospital beds, wheelchairs.

2. Class II
Subject to General Controls and Special Controls with and without exemptions
This class has low to medium to high risk devices; examples of the low to medium risk
devices include hearing aids, electrocardiographs, ultrasonic diagnostic equipment,
drapes - surgical, urological, etc.
Examples of medium to high risk devices in Class II are surgical lasers infusion pumps
(non‐implantable), ventilators, intensive care monitoring equipment.

3. Class III
Subject to General Controls and Premarket Approval

 Class III devices are high risk devices; failure would result in adverse health consequence or fatality. These are usually life sustaining, and or life support devices. Examples include balloon catheters, prosthetic heart valves, Implantable pacemaker pulse generator, implanted diaphragmatic/phrenic nerve stimulator, pacemaker battery, etc. Classification of a medical device depends on two factors, its use and its risk to patient or user. The degree of control is a function of the risk level; or put differently, it is a function of the propensity for adverse loss due to malfunctioning of the device. Apparently, Class I devices pose lesser risk to the patient or user, while Class III devices pose greater risk. Notice that Classes I &II may enjoy some exemptions, while Class III does not. The level of risk associated with a device may be deduced from its use, hence the importance of use to the classification process.

The indicated and intended use greatly impact medical device classification. The intended use of a device is fundamentally the purpose of the device; it predicts the risk level and drives its classification. Medical product labeling is also big on intended use as stipulated in title 21 CFR Part 809.

Determine Classification

The FDA maintains a classification database of medical devices at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Once at the site, simply type in the name of the device and choose the item or that which best resembles your device from the list of results. Double click on your choice of device to see the class and other details including controls and exemptions, etc.

References
FDA (2011). Product Classification. Retrieved from
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
FDA (2011). Presentation: Overview of Regulatory Requirements ‐ Medical Devices. Retrieved from http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126245.htm
FDA (2010). What is a medical device? Retrieved from
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm
FDA (2010). What does it mean for FDA to "classify" a medical device? Retrieved from
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm

FDA (2009). Device Classification. Retrieved from
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyY
ourDevice/default.htm.

Please direct all questions, comments, and or suggested future topics to the author:
Christian Yorgure
Director of Research & Development
Light Fabrications, Inc.
cyorgure@lightfab.com