Author: Suzanne Broussard, PhD | January 5, 2021
The increasing number and complexity of medical devices with several functions prompted FDA to provide medical device manufacturers with premarket and postmarket regulatory guidance. In a nutshell, FDA states that it shall not regulate non-device functions of a product with multiple functions – but can consider the impact of non-device functions on the device functions. The guidance identifies the principles and premarket review practices, postmarket requirements, and multiple examples of the application of the policy.
The term “multiple function” device was first officially addressed by FDA in the 21st Century Cures Act Section 3060 that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance amended the definition of “device” removing certain software functions (medical and decision software support) and clarifies which software functions (analyze or interpret medical data) remain under FDA’s oversight.
The Multiple Function Device Products: Policy and Considerations Guidance for Industry and Food and Drug Administration extends that policy to the assessment of all multiple function device products, whether those functions are hardware-based, software-based, or both.(more…)
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