Medical Devices Definition

According to Section 201(h) of the Federal Food Drug & Cosmetic Act a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that 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.
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."

Entering the U.S. Medical Device Market

Before a company can market a new device, manufacturer must obtain FDA clearance to market the device in the form of premarket clearance (also known as a 510k) or premarket approval (PMA) unless the device is exempt from premarket approval. You will also need to fulfill:

Premarketing requirements
Comply with labeling regulations
Register the manufacturer with FDA (form 2891)
List medical device with FDA (form 2892)
Post marketing requirements
Comply with Quality Systems regulation
Comply with Medical Device Reporting regulation

Market Approval

The first step in the gaining marketing approval from FDA is to classify the medical device. FDA classifies each device type into one of three classes—class I, II, or III—based on the level of risk it poses and the controls necessary to reasonably ensure its safety and effectiveness. Examples of types of devices in each class include the following:

Class I

Class I devices are subject to the least regulatory control as they present minimal potential for harm to the user. Class I devices are subject to "General Controls". Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Most Class I devices are exempt from the premarket notification.

Class II

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Some Class II devices are exempt from the premarket notification.

Class III

Class III devices are those for which insufficient information exists to assure safety and effectiveness. These include devices that:

Support or sustain human life, or
Are of substantial importance in preventing impairment of human health, or
Presents a potential, unreasonable risk of illness or injury

Examples of Class III devices which currently require a premarket notification include implantable pacemaker pulse generators and endoosseous implants. Class III devices must generally obtain an approved PMA, but until FDA issues regulations requiring submission of PMAs, certain types of class III devices may be cleared via the 510(k) process.

The classification level of your device can be determined by searching the FDA’s Device Advice Database and go to the Device Classification Panels- http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051530.htm
Or, search the CDRH classification data base http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm]

In general, unless exempt under FDA regulations, devices are subject to one of two types of FDA premarket review before they may be legally marketed in the United States:

Premarket approval (PMA): The manufacturer must provide evidence, typically including clinical data, providing reasonable assurance that the new device is safe and effective. The PMA process is the most stringent type of premarket review. A successful submission results in FDA approval.

Premarket notification (510(k)): The manufacturer must demonstrate to FDA that the new device is substantially equivalent to a device already legally on the market that does not require a PMA. A successful submission results in FDA clearance.

In general, class I and II device types, subject to premarket review, are required to obtain FDA clearance through the 510(k) process, and class III device types are required to obtain FDA approval through the more stringent PMA process.

Research by Eliza Brannigan & Kristin Stiner