Simple Guide to Understanding Medical Device Classifications

Medical Device Classification Explained in Easy Terms: Bandages, Autoclaves, and More

Who categorizes the medical devices?

The FDA, a large organization with a complex structure, plays an important role in regulating a wide range of medical equipment and products in the United States. More specifically, the?Center for Devices and Radiological Health (CDRH), a department within the FDA department,?assigns these class numbers.

CDRH works tirelessly to ensure the safety and effectiveness of the devices – everything from the bandages you buy at the pharmacy to the intricate workings of the heart valve.

This department is dedicated to protecting public health by ensuring that medical devices manufactured in the US are safe and effective. Additionally, its research and cataloging provide security to healthcare professionals, patients, and users.

What are the differences between Class I, II, and III medical devices?

Breakdown of the Classification of Medical Devices per the FDA

Medical devices are categorized by:

• how risky is the equipment/product
• how will the equipment/product be used
• how much training is needed to use the equipment/product and technological characteristics

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Source:? Center for Devices and Radiological Health (CDRH)

What does a Class I Medical Device classification mean?

• The product/equipment has the lowest risk of use: These devices present minimal risk to the user.
• It is a simple design: The product/equipment is straightforward in design and function. ?
• Not much training is needed to use it.

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Examples of Class I medical devices

• Bandages (adhesive and non-adhesive)
• Gauze pads
• Surgical masks
• Medical gowns (non-surgical)
• Bedpans and urinals
• Stethoscopes (manual)
• Reflex hammers
• Scalpels (reusable)
• Forceps

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What does Class II Medical Device mean?

• These products/equipment are moderate risks to the user, patient, or healthcare professional.
• These products/equipment are more complex than Class I: These devices generally are more complicated in design.
• This product/equipment requires operator training.
• This product/equipment must be tested in a real-world setting before approved.
• This product/equipment requires approval from the FDA. ?

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Examples of Class II medical devices

• Autoclaves
• Blood pressure cuffs (automatic) ???
• Thermometers (digital)
• Oximeters
• Ultrasound machines ?
• X-ray machines (some types)
• MRI machines ?
• Infusion pumps ??
• Catheters
• Defibrillators (external)

What does Class III Medical Device mean?

• It's a high-risk product: These devices pose the most significant risk to patients, potentially leading to serious injury, illness, or even death if they malfunction or are misused.
• They sustain life: They often support or sustain human life or play a crucial role in preventing health impairment.
• The medical device is implantable.

Class III devices, the highest risk category, undergo a rigorous review process by the FDA. This process, which includes extensive clinical trials and a thorough review, ensures that these devices are safe and effective, instilling confidence in their users.

?Examples of Class III medical devices

·?????? Pacemakers

·?????? Defibrillators

·?????? Heart valves

·?????? Artificial hips

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Why is this Classification system important to medical device manufacturers?

Making a new medical device isn't easy. There are many rules to follow to ensure the medical device is safe and performs as intended.

Bringing a medical device to market takes time and money, but it's important because these companies are experts at ensuring the devices we use are safe.

• Class I: Manufacturers of Class I devices face the least regulatory burden. They typically only adhere to general controls, such as good manufacturing practices and proper labeling. This category is easier and less expensive to bring devices to market. ?

• Class II: Manufacturers of Class II devices must comply with general and unique controls. This includes performance standards, post-market surveillance, and premarket notification requirements (often through a 510(k) submission). These requirements increase the complexity and cost of the regulatory process. ?

• Class III: Manufacturers of Class III devices, the highest risk category, face the most stringent regulatory requirements. These devices typically require premarket approval (PMA), which involves extensive clinical trials and a thorough review by the FDA. This process is the most time-consuming and expensive, often requiring significant investment in research and development. ?

A device's Classification also affects how it is marketed and labeled. Manufacturers must ensure that their training, marketing materials, and labeling comply with FDA regulations for the specific device class.??

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What are some of the costs associated with developing a medical device?

The more technology, innovation, development, marketing, regulatory requirements, and time a medical device manufacturer must undergo, the higher the overall manufacturing cost to bring that equipment/product to market.

Below is an example of manufacturers' typical expenditures when developing a medical device.? Estimated costs depend on the Classification of the product.

Which medical device classification is a PRIMUS healthcare steam sterilizer?

A PRIMUS healthcare steam sterilizer is considered a Class II medical device in the United States. Here's why: ?

• Autoclaves are a moderate risk: Steam sterilizers are essential for infection control, but they pose a moderate risk if they malfunction or are misused. Ineffective sterilization can lead to serious infections in patients. ?
• Autoclaves have their hoops to jump through. Proper use requires special training and familiarity with the equipment. Therefore, steam sterilizers are subject to the FDA's approval of how the equipment's controls work on the unit.

• Performance standards: Does the sterilizer meet specific standards set for sterilization effectiveness? ?

• Premarket notification (5I0k): Is the new device similar to an existing, approved device?

• Post-market surveillance: Monitoring and reporting the device's performance in real-world use.

Why isn't a steam sterilizer (Autoclave) considered a Class I medical device?

Class I devices have the lowest risk and are subject only to general controls.

A steam sterilizer, which can potentially impact patient safety if it fails to sterilize medical equipment properly, clearly exceeds the risk level of a Class I device. ?

Why isn't a steam sterilizer (Autoclave) a Class III medical device?

Class III devices are the highest-risk devices and typically support or sustain human life. While crucial for infection control, a steam sterilizer does not meet the criteria for a Class III device as it does not directly support or sustain human life. Therefore, it falls into the Class II category.

While a malfunctioning steam sterilizer can have serious consequences, it doesn't typically pose the same immediate, life-threatening risk as a Class III device (like a heart valve).

Summary

From bandages to pacemakers, the FDA's medical device classification system, overseen by the CDRH, plays a critical role in safeguarding public health. Understanding the distinctions between Class I, II, and III devices empowers patients, manufacturers, and healthcare professionals.

The FDA's classification system ensures that medical devices, like a PRIMUS healthcare steam sterilizer (Class II device), are evaluated for safety and effectiveness before being released into the market.

The FDA balances manufacturing innovation, patient protection, and healthcare provider use by classifying a device based on risk and intended use.

·??????? Device manufacturers need to know the Classification of their devices to comply with FDA regulations.

·??????? Patients need to understand device classifications to familiarize themselves with the complexity of the devices used for their care.

·??????? Healthcare providers need to understand device classification to decide which devices are appropriate for patient needs for a procedure.

For more information about medical device classification

?The FDA website has much information about submitting new medical devices; finding precisely what you need can be overwhelming. Here's a breakdown of where to find the key information and how to navigate it:

1. Start with the "How to Study and Market Your Device" page: ?

• This FDA website link is a good overview and a roadmap for the entire process. You can find it here: https://www.fda.gov/medical-devices/how-study-and-market-your-device

2. Learn about Device Classification:

• Before submitting anything, you must know how your device is classified (Class I, II, or III). This submission determines the type of submission required. You can find information about device classification here: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device#classify ?

3. Choose the Correct Premarket Submission:

• Choosing the correct premarket submission is the most crucial step. The FDA has different types of submissions depending on your device and its risk level. Common types include:

• 510(k) Premarket Notification: For devices substantially equivalent to already marketed devices.

• Premarket Approval (PMA): For new, high-risk devices. ?

• De Novo classification: For new devices with no predicate. ?

• You can find information about selecting the correct submission type here: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/premarket-submissions-selecting-and-preparing-correct

4. Understand the eSTAR Program:

• The FDA is moving towards electronic submissions using the Electronic Submission Template And Resource (eSTAR). Electronic submissions are required for most 510(k) submissions. Learn more about eSTAR here: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program ?

5. Use the CDRH Portal:

• The Center for Devices and Radiological Health (CDRH) Portal is where you'll submit your premarket submissions. You can find information about the portal here: https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal ?

Important Tips:

• Use the FDA's search function to help you find specific guidance documents and resources. ?

• Look for guidance documents: The FDA publishes many documents that provide detailed information on specific topics. ?

• Consider contacting the FDA: If you have specific questions, you can contact the FDA directly for assistance.