Understanding the policies for your Medical Device Software Functions
Manufacturers and authorities are often experiencing uncertainty when classifying their software under regulatory specifications.
It is important for any company developing Software as a Medical Device (SaMD) to understand their device's required regulatory oversight based on FDA classifications. Regardless of the shape, size, or platform, this subset of devices is still taken with the same administering caution as any medical device out on the market.
Definitions to know
Understanding the terminology surrounding software functions in the regulated industry will give SaMD startups a head-start on defining a regulatory approach for your “device software functions”.
Policy for Device Software Functions and Mobile Medical Applications
Now that you know the terminology, you are ready to discover how as a manufacturer you can find the right regulatory approach for your medical device.
In 2019, the FDA’s updated its regulatory guidelines for device software functions into two categories:
Software functions under FDA’s regulatory oversight
Identifying specific regulatory requirements for your device becomes more straightforward when you can define the type of software functions your device contains.
Software functions may take a number of forms, but it is important to note that the FDA intends to apply its regulatory oversight to only the subset of software functions who may have a higher level of risk. These specific type of software functions can transform a general-purpose computing platform or mobile platform into a regulated medical device. They are listed below:
Because of the low-risk nature of the following devices, the FDA only intends to exercise "enforcement discretion" on this subset. In other words, the FDA will not expect manufacturers to submit premarket review applications or to register their software with the FDA. These device software functions are usually designed to:
Risk Classifications for Medical Devices
Now that you know if your device software function is considered a medical device under FDA’s regulatory policy, you will have to adhere to the rules of your device’s Risk Classification.
Depending on the Risk Classification for the device software function, manufacturers are required to implement the proper controls to ensure a record-keeping of safety.
Regulatory Requirements for Device Software Functions
Now that you know where your device software function(s) stand under the FDA’s classification, you are in charge of complying with the Quality System regulation, also known as QS.
This regulation basically states that manufacturers of software functions that are considered medical devices are required to follow “good” manufacturing practice. In other words, the FDA wants manufacturers to be able to follow a set of regulations to prevent a user or patient harm or instill proper corrections when there is an inaccuracy.
The QS does not explain in detail how a manufacturer must produce a specific device but instead provides a framework for all manufacturers to develop applicable requirements and specifications for the design, production, and distribution of the device.
How to get your device on the right regulatory path
Deciding the correct regulatory approach for your medical device can be a hectic process mainly because it requires a high level of documentation. Manual documentation can further lag development processes.
Here at Sierra Labs, we developed an out-of-the-box QMS for medical device startups with built-in document automation tools to streamline compliance processes. Sierra Quality Management System (QMS) offers you a robust start to identifying relevant regulatory requirements pertaining to your SaMD's risk classification.
Sierra QMS is designed for SaMD startups looking to market their solutions in a global regulated environment. Our solutions allow you to easily integrate risk management into your production process and operate with your own preferred tool-sets.
Want to see how Sierra QMS can automate your documentation processes?
Contact us for a free demo below!
Easy compliance starts here.