A medical device inspection is one of the most important activities the FDA carries out to determine that a device meets the requisite regulatory standards for ensuring safety and effectiveness. It is a core GMP activity and hence covers all medical devices ranging from the smallest to complex ones such as MRI’s.
Rationale for the medical device inspection regime
The medical device inspection process is built on the logic that methods are not to be considered the criterion for evaluating and inspecting a medical device. This is because many methods can be used to arrive at the same product, due to which the choice of the best option is left to the manufacturer. Given this fact, the FDA medical device inspection concept is aimed at inspecting the device’s Quality System Regulations (QSR)-mandated objectives, which are a more precise parameter for medical device inspection.
What are manufacturers expected to demonstrate to a medical device inspection?A medical device inspection is done to ensure that the device meets set safety, efficiency and intended use standards, while being compliant with regulatory requirements. During the medical device inspection, manufacturers have to demonstrate that the method they have chosen to use -since there can be varied methods for arriving at a medical device specification -is helpful in arriving at the product while meeting the prescribed regulatory compliance requirements. They should defend the methods they have used in ensuring regulatory compliance requirements.
Factors a medical device inspection takes into considerationDuring a medical device inspection, the FDA inspectors keep in mind a few factors that help them determine the efficiency and effectiveness of a medical device. Some of the important ones among these include:
- Has the manufacturer documented the processes in the right format? Has everything related to it been written down?
- Is the manufacturer complying with those processes?
- Is there sufficient evidence that these are adequate?
Other issues for a medical device inspectionThe FDA does a medical device inspection keeping these factors in mind while also weighing other issues such as the size of the medical device manufacturing firm, the complexity of the device under inspection, and the nature and gravity of risk a device that does not meet its intended specifications poses.