The Food and Drug Administration (FDA) has released a finalized guidance which provides directions for sponsors on US Food and Drug Administration (FDA) to review the medical products that perform both medical and non-medical functions. The newly issued policy and considerations are in accordance with the provisions of the 21st Century Cures Act (Cures Act).
This guidance is aimed at clarifying the FDA’s policy for products with multiple functions that include at least one device function, according to the 21st Century Cures Act. Find out more. https://t.co/8pO7AytZOr
— FDA Medical Devices (@FDADeviceInfo) July 28, 2020
The 21st Century Cures Act (Cures Act) does not include some of the software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new released document follows an April 2018 draft guidance. It explains and clarifies how and when the FDA plans to analyze the effect and result of the “other functions” of a product when those functions are not the subject of a premarket review.
The guidelines extensively give the demonstrative example of policies application. “The purpose of this guidance is to identify the principles, premarket review practices, and policies for FDA’s regulatory assessment of such products,” said FDA in the guidance.
As per the Cures Act, If a product happens to have a software non-device function and a device function, FDA is then authorized to analyze how the non-device function effects the device function, as part of its regulatory function of assessing the safety and effectiveness of the device function. “FDA believes that a similar approach should be used for the assessment of all multiple function device products,” the agency wrote.
FDA explained that the medical equipment may consist numerous functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not. Therefore, according to FDA, it was confirmed that the products that have at least one device function and one non-device function, or happens to have other function, fall within the definitive category of the “multiple function device products.” To give the demonstrative example, FDA talked about the application of skin cancer detection software with the software app, devised in a way that it could tests the skin cancer.
Generally, the FDA may analyze the effect of the other function on the device functions, should other function considerably impact a device function of the product. Therefore, the FDA further explained that “In accordance with existing policies, FDA intends not to review a device function subject to an enforcement discretion policy merely because it is part of a multiple function device product.”
The guidelines may extend the software-based principles of the Cures Act to other non-software multiple function device products. Yet, these guiltiness does not give the clarification regarding what and why exactly functions do or do not meet the definition of devices. However, for the assessments in premarket, it is must for the manufacturers to determine if there is any ‘other function’ that could impact the safety or effectiveness of the device function-under-review, says the FDA.
The extensive considerations to analyze the “other functions” are given in the guidance, on the form of a flowchart to aid in assessing the impact of “other functions” on the device function. The guidelines also give the points to consider in risk-based safety assessment and any impacts on effectiveness or performance of the device.
The final guidance, issued jointly by FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiologic Health (CDRH) and Center for Biologics Evaluation and Research (CBER), has been added to the draft guidance by including considerations for multiple function device products that may be subject to biological license application (BLA) premarket review.