Green Circle Talks About Crossing the Border] Correct Classification of Medical Devices in the U.S.

Below is a detailed description of the U.S. Food and Drug Administration's (FDA) classification of medical devices and their compliance requirements:

01 Definition of medical device

The U.S. FDA defines a Medical Device under Section 201(h) of the Food, Drug, and Cosmetic Act:

• Instruments, equipment, apparatus, machines, appliances, implants, in vitro reagents or calibrators, or other similar or related items, including parts or accessories;
• For the diagnosis, monitoring, mitigation, treatment or prevention of disease, in humans or other animals;
• Affects the structure or function of the human or other animal body and does not pass through chemical action in the human or animal body or depend on the production of metabolic changes for its intended use.

02 Importance of Accurate Classification of Medical Devices

The classification of medical devices indicates which controls apply to a device and what regulatory submissions, if any, are required for the marketing of that device. Where a device is subject to certain controls and/or regulatory requirements, these must be strictly adhered to.

• If a medical device imported into the U.S. is not properly categorized for compliance, the FDA will determine that the device is adulterated or mislabeled, and the company may be at risk of having its shipment withheld, denied entry, or blacklisted.
• Some domestic devices differ from U.S. devices in terms of accurate categorization and compliance requirements, and therefore exports to the U.S. must be accurately judged in accordance with U.S. FDA regulations.

03 FDA Medical Device Classification Rule

The FDA categorizes each medical device into three classes (I, II, and III) according to its risk level. The higher the risk level, the more stringent the regulatory requirements, with Class III having the highest risk level and Class I having the lowest.

Medical device categorization determines the type of premarket notification/application required for FDA marketing approval based on the level of risk it poses, but also on the device's Intended use and Indication for use.

04 Distinction between Class I, Class II and Class III medical devices

Class I Medical Devices - General Controls

• Not be used to support or sustain life or to prevent harm to human health, and may not pose a potential unreasonable risk of illness or injury.
• Low/medium risk to the patient, little to no contact with the patient, minimal impact on their overall health.
• Most Class I medical devices are not required to submit a Premarket Notification 510(k) or Premarket Approval (PMA) prior to marketing in the United States.

Examples of Class I medical devices::

• Bandages
• bed pan
• tongue depressor
• Surgical masks
• Flushing dental syringes
• razors

Class II Medical Devices - General and Special Controls

• General controls are not sufficient to adequately assure the safety and effectiveness of the device.
• Moderate/high risk to patient, continuous contact with patient and therefore higher risk.
• Most Class II medical devices require a 510(k).

Examples of Class II medical devices::

• Blood Pressure Cuff
• syringes
• Blood Transfusion Equipment
• Electric wheelchair
• Contact Lenses

Class III Medical Devices - General Controls and PMAs

• Usually used to maintain or support life, implanted in a patient, or with an underlying, unreasonable risk of disease or injury.
• With the highest risk to patients, all Class III devices require PMA approval prior to marketing.

Examples of Class III medical devices::

• implantable pacemaker
• Breast implants
• defibrillator
• High Frequency Ventilator
• cochlear implant
• Fetal blood sampling monitor
• Implantable Prostheses

05 How do you determine your medical device category?

Seeking FDA Medical Device Compliance Consultation Green Circle Team

Provide a product description and the Green Circle team will guide you through the precise categorization.

Other methods of determining the type of medical device:

Manufacturers can make their own inquiries by visiting the FDA website:

1. View the FDA Medical Device Classification Panel (a list of medical device classes based on medical specialty).
2. Find the FDA regulations and product codes associated with the product.

Submission of 513(g) applications to FDA

Formal instrument identification or classification may be obtained for a fee.

This information can help you fully understand how the FDA categorizes and regulates medical devices prior to export, making compliance easier.