When does a radiology AI marketplace need regulatory certification?
In a world of continuous AI innovation, we regularly hear about new models being developed, tested and advertised for medical purposes without regulatory certification. The radiology AI space, now the most saturated of all FDA-cleared AI-enabled medical devices, also faces this issue so you might ask yourself, how can you access AI models, easily, and securely, which are certified?
An AI marketplace may just be the answer. Some AI marketplaces like CARPL.ai and Augmento also have their own regulatory certification, while others don’t. Buyers of AI platforms should be aware of what they are buying, and why some AI marketplaces might have additional helpful features that are regulated.
What is an AI marketplace?
An AI marketplace is a platform which allows users access to a range of AI devices for them to choose and subsequently use. It connects people with AI solutions to best suit their needs and solve not only one problem but potentially a multitude of problems. In the radiology AI space, a radiologist may access an AI marketplace and select three models to support their work by 1) Drawing a heatmap over an image to highlight abnormalities, 2) detecting and triaging said abnormalities, and 3) report writing and generation. You can think of it like Apple's AppStore or Google Play Store, but specifically for AI applications that have achieved appropriate medical device certification.
An AI marketplace which only facilitates access to regulatory-certified AI systems does not always need its own medical device regulatory certification, but what features will cross the line?
When does an AI marketplace need regulatory certification?
There are cases where a platform hosting an AI marketplace may need medical device regulatory certification.
To think about this, let’s take a step back and think about the tools commonly used within Radiology. A Picture and Archiving system (PACS) viewer, which displays the medical images for review (or now, “Medical image management and processing software”, in US FDA terms), can fall under a number of regulations. Simple image viewers fall under Regulation CFR 892.2020, as a “Medical image communications device”, in the US making them a Class I device exempt from the premarket notification procedures. Depending on the jurisdiction, however, these devices still need to be developed under part of or a full Quality Management System. These products do not need regulatory certification but are limited in scope - they can only be used for “simple image review software functionality for medical image processing and manipulation”. This software does not perform advanced image processing or complex quantitative functions.
If you have a PACS viewer which does perform more advanced or complex image manipulation or enhancements (e.g. segmentation) or complex calculations (e.g. semi-automated measurements), this device would fall under CFR 892.2050, as a “Medical image management and processing system”. These devices do require regulatory certification as Class II medical devices.
Now, back to the AI marketplace:
- If your marketplace is a standalone integration within existing PACS systems, you do not need regulatory certification.
- If your marketplace is integrated within your own PACS viewer, which only provides simple image review functionality, your product would likely be a Class I device and exempt from premarket notification, but still needing to be developed under the Design Control part of a Quality Management System for the US and under a full Quality Management System for the EU.
- If your marketplace is integrated within your own PACS viewer, which provides more complex features and functionality, your device will need regulatory certification, likely as a Class II device.
Importantly, these regulatory certifications would not be for the AI marketplace itself, but rather for the platform within which it is integrated.
What AI marketplaces have FDA certification?
Currently, there exists a number of AI marketplaces, or integrations, available to use, that either do not require regulatory certification, and a number with certification for their PACS viewers such as those provided by TeraRecon and Sectra. These marketplaces provide the ability for dozens of regulatory-approved AI models to integrate within native PACS viewers of choice. What about the whole package? A PACS viewer that can process medical images, and provide AI integrations? That is where the likes of CARPL.ai and Augmento come in.
Both CARPL.ai and Augmento are PACS viewers, which provide the viewing and post-processing of medical images in the aid of their interpretation by trained professionals, and are both 510(k) certified as such (K232891 and K222781, respectively). Not only that, both devices boast an AI marketplace allowing the integration of third-party models, allowing a level playing field from which users are able to pick and choose the best AI model that suits their needs. Interestingly, the AI marketplace within Augmento is facilitated by CARPL.ai, who claim to be, as Dr Vidur Mahajan, CARPL.ai CEO, says, “the largest AI marketplace within an FDA-certified device”.
For radiology AI manufacturers, these marketplaces have more benefits than just ease of integration:
1. A partnership with AI marketplaces may allow for wider adoption and use of your device, beyond those of any direct consumer-manufacturer partnerships,
2. Often, AI marketplaces are responsible for the integration with PACS viewers, some even hosting their own containerised versions of these AI models and reducing implementation overhead,
3. Integration with these marketplaces has the potential to provide a wealth of both pre-and post-market data which can not only be used to support and sustain certifications pre- and post-market, but also provide data for further product development.
Alternate jurisdictions
We’ve discussed the US FDA’s view on radiology AI marketplaces but what about under CE, or UKCA? Thankfully, these regulations are all aligned, with the AI marketplace not meeting the definition of a medical device in any of these jurisdictions. Just as above, any PACS viewer which does provide complex medical image processing will require regulatory approval in the respective jurisdiction. Have a look at our recent article where Mike Pogose, Hardian Health's Director of Quality Assurance & Regulatory Affairs, explains how to classify medical signal or image analyser software.
Whilst under EU MDR the operator of an AI marketplace won’t necessarily require their own regulatory certification, they could be deemed a distributor. The EU MDR defines a distributor, in Article 2(34), as “‘any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service”; making available on the market is also defined, in Article 2(27), as “any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;”. There are a number of requirements that the operators of these marketplaces, as medical device distributors, must adhere to. The European Commission has created a helpful factsheet around this, but generally, the requirements of medical device distributors include, but are not limited to:
Making sure that the devices they place on the market bear the CE marking
Making sure that the devices are accompanied by the required information and labelled in accordance with the Regulation
Making sure that the devices have been assigned a UDI, where applicable
Verifying that devices are registered in EUDAMED
The marketplace operator should then have a contractual agreement with the original AI manufacturer that lays out the responsibilities of each party; complementarily, the manufacturer needs this agreement, under their Quality Management System, as the distributor is in effect providing a service to the manufacturer - that is making their device available on the market.
But be careful of one gotcha: if the AI application is offered under the name of the marketplace operator, rather than the name of the original manufacturer, then the marketplace operator takes on the responsibilities of a manufacturer: this is all laid out in Article 16 of the EU MDR; a manufacturer is “a natural or legal person who … markets that device under its name or trademark” per EU MDR Article 2(23).
