Classifying a Class III Medical Device

For Classifying a Class III Medical Device the FDA established certain regulatory controls in the form of general controls and special controls. The classification of medical devices (Class I, Class II or Class III) will determine the type of regulatory controls the FDA imposes to ensure the device’s safety and effectiveness before being placed into commercial distribution in the US.

When it comes to medical device classification per FDA requirements, it essentially comes down to the level of benefit and risk posed by the product and the level of control needed to ensure adequate safety. Class I devices present minimal harm to the patient and are generally simple in design, while class II poses a higher degree of risk. Classifying a Class III Medical Device applies to the high-risk types of medical devices that are deemed very important to health or sustaining life.

• Regardless of the specific Classifying a Class III Medical Device, if clinical data is required for clearance or approval, the clinical investigation must be conducted one of two ways:

1. If it poses a Significant Risk (SR), it must follow the FDA’s Investigational Device Exemption (IDE) protocol
2. If it does not pose a significant risk, it will go before an Investigational Review Board

• Examples of the types of medical devices that fall under class III include:

1. Cochlear implants
2. Implantable pacemaker pulse-generator
3. Renal stents
4. Wearable automated external defibrillators
5. High frequency ventilators

For Classifying a Class III Medical Device, the manufacturer will undergo the highest level of FDA scrutiny and associated costs. The majority of devices are considered a class I or class II, with only 10% receiving the class III designation.

• Knowing how your medical device is classified matters for the following reasons:

1. Product classification will determine what you have to do before you can sell your product.
2. Product classification will help you establish requirements during the product development phase, specifically design controls.
3. Product classification is an important component in determining how much it will cost to bring your device to market and give you some idea of how long it will take.

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