Final FDA Guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types
This article is a follow-up of the article on the Draft guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.
The FDA released the final version of two guidances in December 2016 (yes, I know, I'm a bit late. But you see, this blog is still alive...). One on the medical devices accessories and one on postmarket management of cybersecurity in medical devices.
Let's see what changes the FDA made to the medical devices accessories guidance, compared to the draft version.
Medical Device Accessories
This guidance didn't suffer many changes. The guidance describes what the FDA considers an accessory to a medical device and how it regulates them. Accessories with risk profile different from their parent devices may fall within a different class than the device with which they're intended to be used.
The truly interesting changes are those clarifying the status of software as a medical device:
FDA intends for the risk- and regulatory control-based classification paradigm discussed in this guidance to apply to all software products that meet the definition of an accessory, including those that may also meet the definition of “Software as a Medical Device (SaMD).”
Thus SaMD intended to support, supplement, and/or augment the performance of one or more parent devices are medical devices accessories and may fall within a class different from their parent devices. This actually opens the door to the De Novo clearance process for SaMD with no "easy" predicate.
Another truly interesting change, compared to the draft version, is the examples on articles used in conjunction with the device, which do not fall in the definition of accessories:
FDA would generally not consider a mobile phone that is used as a general platform for applications that include mobile medical applications that are medical devices or an off-the-shelf computer monitor used to display medical data as accessories unless they are specifically intended for use with such medical devices.
non-device-specific off-the-shelf replacement parts (e.g., batteries, USB cables, computer mouse, etc.) may be used with a medical device, but FDA does not intend to consider these products to be accessories or medical devices.
These two examples are welcome. How many times newcomers in the world of SaMD have asked if these types of articles are medical devices. It's way better written in back and white.
Not so much new things compared to the draft guidance. The FDA confirms their approach on medical devices accessories, allowing to place accessories in a class different from their parent devices, and opening the gate to the De Novo process.
Besides that, the examples found in this guidance about off-the-shelf hardware are very helpful to determine if such articles are accessories of software medical device or not.
The next article is on postmarket management of cybersecurity in medical devices.