FDA classifies medical devices into different categories based on their risk factor. Each class of medical device holds different rules and regulations as every one of you would want a medical device to undergo a more detailed inspection and analysis which is going to enter your body such as a pacemaker. Hence, the FDA imposes more rules and regulations for a class III medical device to undergo.
What Are Class III Medical Devices?
FDA classifies high-risk medical devices under class III. According to the FDA, Class III medical devices support human life and prevent impairment of human health. And these class III devices hold unreasonable risk of illness and injury. So, the risk level of Class III medical devices is very high.
These devices make up only 10% of the US medical device classification.
As class III medical devices hold high risk they are subjected to general controls and premarket approval by the FDA. The premarket approval process for class 3 medical device involves detailed study of clinical and non-clinical data. As a concern of safety and efficacy of medical devices of class 3 continuous post-marketing monitoring should be done by the manufacturers of these devices.
Examples Of Class 3 Medical Devices:
FDA Class 3 medical devices include life supporting devices such as:
Pacemakers: This device is placed inside the chest to regulate abnormal heart activities.
Implanted prosthetics: Artificial device placed inside the body through surgery to replace any organ such as limbs, etc.
Cochlear implants: Artificial electronic device used for producing sense of sound.
Defibrillators: This is the device used to produce artificial shock to the heart to bring back its rhythm.
Breast implants: These are silicone implants used for mastectomy.
Fetal blood sampling monitors: Device used to collect fetal blood samples during pregnancy to detect abnormalities if any.
Neurostimulators: Devices used to send electric impulses to specific nerves.
Artificial joints: These are artificial joint replacements such as hip-replacement or joint-replacement.
Heart valves: These are artificial mechanical or biological valves placed to ensure proper blood flow.
Implantable cardioverter defibrillators (ICDs): Artificial devices placed inside the chest to monitor heart rhythms.
SaMD is a medical device (SaMD): Software that follows class 3 regulations of the FDA and functions as class III medical device.
How To Determine If Your Device Is Of Class III Category?
The class of your medical device can be determined by checking on the FDA’s official page where 21CFR Parts 862-892 is mentioned. Here FDA has 1,700 distinct devices from where you can find your device category under various subheads mentioned.
FDA also has its database system from where you can determine the type of your medical device.
For example, you want to find the type of Pacemaker Battery you can search this in the database system, and it will display all the details of the Pacemaker Battery where its category will also be mentioned, that is class 3 as highlighted below:
Pre-Market Approval (PMA) Process For Class 3 Devices By FDA:
All class III medical devices are subjected to the premarket approval process by the FDA. This process is lengthy and requires time as all the clinical and non-clinical data is studied considering the risk factor. Only after the approval of your premarket application process, you are eligible to sell your medical device in the market.
For a detailed overview of the premarket requirements of the FDA you need to go through the FDA’s 21 CFR Part 814 page.
FDA Class 3 Medical Device Approval Process:
Class 3 medical device regulations involve a lengthy process of approval where, on each step the device is analyzed in depth, as class 3 medical devices holds high risk.
The process begins with the pre-submission step where the manufacturer engages with the FDA before the official approval process, however this step is optional. Then the step of Investigational Device Exemption (IDE) comes where the device needs to be included under IDE officially to be used in clinical trials, then the pre-market approval for class 3 devices takes place where comprehensive data of the safety and efficacy of the device is submitted.
FDA then reviews the data and approves or rejects the medical device to be marketed. If the device receives approval, then only it can be marketed, and then post-marketing surveillance (PMS) should be carried on. After PMS if any changes are required in the device, it should be made.
International Regulations for Class 3 Devices:
Every country has its own regulatory body and their rules and regulations who control and coordinate the approval of medical devices. Such as the EU in Europe, the Health Canada in Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the Therapeutic Goods Administration (TGA) in Australia, the National Medical Product Administration (NMPA) in China, the Central Drug Standards Control Organization (CDSCO) in India, etc.
Key points of the Regulatory bodies for class 3 devices are discussed below:
EU Regulation 2017/745 (MDR) controls the approval and market access of medical devices including class 3 medical devices in Europe.
For medical devices in Canada a license application should be submitted including all the clinical and non-clinical data of the device for its approval to the Medical Device Regulations (MDR) or Health Canada.
The Pharmaceuticals and Medical Devices Act (PMD Act) under PMDA regulates the medical devices approval in Japan.
The Therapeutic Goods Act 1989 under TGA regulates medical device approval in Australia.
The Medical Device Supervision and Administration Regulations (MDSAR) under NMPA looks over the approval process of medical devices in China.
In India CDSCO conducts the administration of medical devices with its rules and regulations.
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FAQ’s:
1.What makes Class 3 medical devices different from Class 1 and Class 2?
A: Class 3 medical devices are high risk devices as they are administered inside our body whereas Class 2 devices hold moderate risk and Class 3 devices hold low risk.
2.What safety standards apply to Class 3 medical devices?
A: Safety standards such as ISO 13485:2016, iso 1471:2019, etc. apply to Class 3 medical devices.
3.Can a Class 3 medical device be sold in multiple countries?
A: Yes, Class 3 medical devices can be sold in multiple countries as per the country’s rules and regulations.
4. Are Class III medical devices classified as high risk?
A: Yes, Class III medical devices are classified as high risk as they are administered inside the human body.
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