THE PRINCIPLES OF EXEMPTED DEVICES

Introduction:

Devices exempted under 510(k) state if the device offers safety and is highly effective on the consumers under the FDA. Exempted Devices which get relaxation by 510(k) are classified by the FDA into Class I type, Class II type, and Class III type.

There are specific regulations mentioned with each generic type of device. The classification regulations, however, come over various categories of devices. Product codes have been prepared to obscure additional clarity about device technology. Each classification and its regulations with several product codes are termed as Exempted Devices.

Classification of the Exempted Devices:

Class I Devices:

FDA has exempted mostly all class I devices from any limitations as it’s very low-risk devices. If a manufacturer company’s device falls into a general category of exempted class I devices as defined in 21 CFR Parts 862-892 issues a premarket notification application. Any FDA clearance is not needed before marketing the device in the U.S under the regulatory act. However, these manufacturers are asked to register their organization and list it under the classification name submitted under FURLS and DRLM.

While it’s pointed out that only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), these devices are not labeled or even maybe termed as sterile.

Examples of Class I devices are bandages, handheld surgical instruments, and non-electric wheelchairs.

Class II Devices

FDA has started a list of special controls under class II devices. It has its limitations, which are exempted from premarket notification requirements under the FDAMA or the Cures Act. The FDA states that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and enable the FDA to redirect the resources. This would then be spent on reviewing submissions to ensure the interest of public health. FDA has to step forward to take necessary action to meet FDAMA and the Cures Act and its requirements. Class II devices are not exempted from any requirements of GMP.

Examples of Class II Devices are CT scanners and infusion pumps for intravenous medications.

Class III devices:

Class III devices are those devices that have a high risk to the patients. These devices support life and are sustainable. This equipment is implanted or is presented with an unreasonable risk of illness or injury.

Examples of Class III devices are the pacemakers and breast implants.

Conclusion:

All Exempted Devices come under the regulatory system board. You need to follow the device’s regulatory specifications to know about the requirements. The FDA has its statutory specifications keeping in mind the health and issues of the general public.

Source: https://pharmdevgroup.com/the-principles-of-exempted-devices/