Running the healthcare system without the use of medical devices is nearly impossible. Medical devices have become an integral part so regulating them is also very crucial. Medical devices are divided into Class I, Class II and Class III based on the risk level they possess. Here we are discussing class II medical devices, types of class II medical devices, requirements and more.
What Are Class II Medical Devices?
Class 2 medical devices are those devices which have moderate to high level of risk for the use it is intended for. Medical devices are classified based on the risk they possess for their use. This is the risk classification system of medical devices. In the US, 43% of devices belong to class II medical devices.
FDA Class II Medical Devices
According to FDA, the medical device classification system is as follows:
CLASS | RISK |
CLASS I | Low to moderate risk |
CLASS II | Moderate to high risk |
CLASS III | High risk |
Devices are classified into class II devices if they require special controls along with the general controls and are necessary to provide assurance for their safety and effectiveness. The special controls include performance standards, post marketing surveillance, dissemination or development of guidelines and other required actions as deemed necessary by the commissioner to provide assurance.
If a device is proposed to be used in supporting/ sustaining human life, the commissioner will examine and identify special controls, if any, which are adequate to provide assurance of safety and effectiveness and describe how such controls might provide such assurance.
International Classification of Class 2 Devices
The International Medical Device Regulators Forum (IMDRF) classifies medical devices into 4 classes, A, B, C & D. Out of which class B and C are for devices with low to moderate risk and moderate to high risk level respectively. For FDA, as we have seen there are 3 classes of medical devices. Class I, II & III. For EU, there are only 3 classes, but the difference is that class II is divided as Class IIa and IIb. Some other countries like Australia and Russia also follow a similar classification system.
EU Class II Medical Devices
CLASS | RISK CLASSIFICATION |
CLASS I | Low risk |
CLASS IIa | Low to medium risk. |
CLASS IIb | Medium to high risk. |
CLASS III | High Risk |
Australia Class II Medical Devices
CLASS | RISK CLASSIFICATION |
CLASS I | Low |
CLASS I (supplied sterile) CLASS I (with a measuring function) | Low to medium risk |
CLASS IIa | Low to medium risk |
CLASS IIb | Medium to high risk |
CLASS III | High risk |
Russia Class II Medical Devices
CLASS | RISK CLASSIFICATION |
CLASS 1 | Low risk |
CLASS 2a | Average degree of risk. |
CLASS 2b | Increased degree of risk. |
CLASS 3 | High degree of risk |
Common Types Of Class II Devices & Examples
In the US, more devices fall under this category compared to the EU. Some common types of class 2 medical devices include:
Infusion Pump: It is a device used to deliver therapeutic fluids or nutrients to a patient in a controlled manner.
Nebulizer: It is a machine that allows for the conversion of liquid medicine into aerosol droplets. It is mainly used to treat respiratory conditions.
Catheter: A tube which is flexible. It is inserted into the body which allows for the transportation of fluids into or out of the body.
Glucometer: An electronic medical device that is used to test the concentration or level of glucose in the blood.
Blood pressure cuff: An inflatable band that is designed to be wrapped around the upper arm to determine blood pressure.
Pulse Oximeter: A device that measures oxygen saturation levels in the blood. It also measures the pulse rate along with it.
Powered wheelchairs: Wheelchairs that are battery powered. They are also known as electric wheelchairs or electric powered wheelchairs (EPW).
Contact lens: These are clear, thin plastic disks that can be worn in the eye to improve vision. It floats on the tear film which covers the cornea.
Class II Medical Device Requirements
As per the classification provided for the medical devices by different regulatory authorities, every authority state one thing. As the classification level goes up so are the regulatory requirements. Regulatory control increases with risk level.
Some basic regulatory requirements that medical device manufacturers must comply with in the US are:
Establishment Registration: The manufacturers as well as the importers of the medical devices must register their establishment with the FDA. All registration information should be annually verified.
Medical Devices Listing: Normally, establishments that are registered with FDA also require to list their devices that are manufactured over there. Activities performed on the devices are added as well.
Premarket Notification 510(k) or Premarket Approval: Some class II devices and most of the class I devices are exempted from 510(k). Premarket Approval or the PMA is a requirement for class III devices, the high-risk class.
IDE (Investigational Device Exemption) for clinical studies: An IDE permits the use of investigational devices to be used in clinical studies or trials to gather safety and effectiveness information prior to its marketing. To support the application by clinical data is required for only a small percent of 510(k) submissions.
Quality System (QS) Regulation: This regulation involves the requirements that are relevant to the methods, facilities and controls used to design, purchase, manufacture, pack, label, store, install and service the medical device. Inspections will be conducted in the manufacturing sites by the authority. It is to ensure that everything is in compliance with QS requirements.
Labeling requirements: The medical device must be labelled. In addition, a descriptive and informational literature must also be provided along with the device.
Medical Device Reporting (MDR): The MDR regulation gives the FDA and the manufacturer a chance to monitor and identify any potential adverse events involving the device. Any serious harm, death, malfunctions caused by the device must be reported to the regulatory authority.
Premarket Notification 510(k) For Class 2 Devices
A person who wishes to market a medical device for human use belonging to any class must submit a 510(k), given that it does not require a PMA. A 510 (k) is not required if the device is excluded from the 510 (k) requirements of the FD&C Act. 510 (k) submissions provide evidence that the device is safe and effective.
There is no specific 510(k) form available but 21 CFR 807 subpart E states the 510 (k) submission requirements. Prior to the marketing of the device, the submitter must get an order from the FDA in the letter form. It must state that the medical device is found to be substantially equivalent to legally marketed devices.
When Is A 510 (k) Required For Class II Devices?
510(k) is required in the following aspects: -
While introducing a device onto the market for the first time, unless any exemptions are applicable to the device. In 1976, after May 28, anybody who wishes to market a device in the US will have to make a 510(k) submission. This submission has to be made at least 90 days prior to marketing the device, even if the device is still developing or under clinical investigation before that date.
If the device is a legally marketed device but any changes/modification to the device affects its safety and effectiveness. The 510(k) holder is responsible for deciding whether the modification affects safety and effectiveness of the device. The modifications must be in compliance with Quality System regulation, 21 CFR 820.
The changes must be recorded in device master record and change control records. It is recommended that a justification regarding the submission and non-submission for a new 510(k) should be recorded in the changes control records. A new 510(k) is required for an existing device if the device is marketed for a new or different intended use.
510(k) Process For Class II Medical Devices
Premarket submissions are sent electronically via the CDRH portal. To 510(k), an eSTAR (Electronic Submission Template and Resources) or eCopy (electronic copy) is sent to FDA. After receiving, a unique control number is assigned to the known 510(k) number or the K number.
FDA conducts verification checks to confirm the following:
1) User fee has been paid for the submission.
2) A valid eSTAR/ eCopy is provided.
If these are not met, the FDA will mail a hold letter to the submitter usually within a week from the receival of 510 (k). The submitter has 180 days to resolve the issue from the date of the hold letter. If not resolved, then the submission will be withdrawn and deleted from the system and a new submission has to be made.
If the verification checks are met, then an acknowledgement letter will be mailed to the contact person. It contains the date of receipt, and the 510 (k) number assigned.
eSTAR submissions are not considered to undergo an RTA (refuse to accept) process. FDA employs a virus scanning & technical screening process for an eSTAR. For eCopy, an acceptance review will be conducted by the lead reviewer with an acceptance checklist.
After an acknowledgement letter is sent, depending on the type of device and medical specialty, 510(k) is routed to the appropriate office & division. A lead reviewer is assigned. Reviewer decides whether the submission meets the minimum acceptability threshold and must be accepted for substantive review.
Following the receipt of submission, within 15 days, the submitter gets an electronic notification of the result of acceptance review. It provides the name and contact information of the lead reviewer assigned to 510(k) and the status of 510 (k).
The Acceptance review result can be either
1) Accepted for substantive review
2) Not accepted for review (will be in RTA hold) (or)
3) Is under substantive review as FDA did not complete acceptance review within 15 days.
At the time of substantive review, the lead reviewer communicates with the submitter via a substantive interaction after a comprehensive review. Additional information can be requested at this time by the reviewer, or an additional information (AI) request will be sent which will put the submission on hold.
A decision is made in 90 FDA days. The decision involves findings of SE (Substantially equivalent) or NSE (not substantially equivalent). The FDA issues a decision letter via email to the submitter when a decision has been made.
If a SE decision is received by a 510(k) then it is considered cleared.
If a decision is not made in 100 days, a Missed MDUFA Communication will be issued to the submitter. This is written feedback stating the reasons that prevent FDA from arriving at a decision.
Development and registration of medical devices are never an easy task. With the increase in class level, more strict regulatory requirements will be applicable. At Artxio, we have regional experts and leaders in the medical device industry who will assist the marketing procedures of the device. Our team of experts make sure that the submissions made are of quality and decrease the chance of rejection. Reach out to us on info@artixio.com
Learn About Class 1 Medical Devices
FAQs About Class 2 Devices
Q. How are Class II medical devices regulated by the FDA?
A. Class 2 medical devices are regulated by implementing general as well as special controls. Class 2 devices require special controls along with general control to assure their safe and effective use. They must be in compliance with these controls.
Q. Do Class II medical devices require FDA approval?
A. Yes, class 2 medical devices require approval from the FDA. To market a medical device, a premarket notification 510 (k) submission is required unless the medical device is exempted from such conditions.
Q. What distinguishes Class I and Class II medical devices?
A. Class I medical devices are devices with low-risk potential for their intended use whereas class II medical devices have an increased risk level. Class II medical devices belong to a moderate to high risk level. Since there is variation in the risk level for both classes, the regulatory requirements also vary for both.
Q. Can a Class II medical device be marketed in the EU?
A. Yes, class II medical devices can be marketed in the EU. Just like other regions, EU MDR has set forward certain rules and regulations to be followed in the development and marketing of the drug. Compliance with these regulations and requirements allows for the marketing of a medical device.
Comentarios