FDA outlines developments for 3D printing, AI & cybersecurity

The FDA’s Center for Devices and Radiological Health (CDRH) is working on new industry policies and regulations for medical device cybersecurity, 3D-printing and artificial intelligence (AI), according to Regulatory Focus.

The FDA spoke at the Association for the Advancement of Medical Instrumentation (AAMI) conference, outlining its plans into each area.

Regarding cybersecurity, it was reported that the agency has spoken with industry and healthcare providers on why it needs to update policies set out in 2014 on medical device design and development recommendations.

FDA’s Center for Devices and Radiological Health (CDRH) is working to create new industry policies and regulations, as well as to further develop existing ones for each of the three topics.

Suzanne Schwartz, CDRH associate director for science and strategic partnerships highlighted that the FDA has plans to update premarket guidance and that the agency is looking into ways at ensuring effective cybersecurity management.

The FDA is also planning to qualify more medical device development tools. The first of these tools – the Kansas City Cardiomyopathy Questionnaire (KCCQ) - approved by the FDA was highlighted as an example.  

On AI, it was mentioned that the FDA doesn’t have any policies in place for continuous learning systems. The agency invited stakeholders for input, so it could define some of the requirements needed by AI health products.

3D printing, specifically anatomical models, were also mentioned as new areas for the FDA.

James Corburn, senior researcher at CDRH, said: “3D-printing is an interesting area because it’s a bit different from what FDA has typically done. Patient-specific devices is a huge area” of new opportunities within 3D-printing because an “infinite number of shapes” can be created at a lower cost for industry."

Recently, the FDA approved a company’s software for 3D printing anatomical models for diagnostic use. Additive manufacturing company Materialise was given FDA approval for its Mimic inPrint software used for pre-operative planning. CDRH staff also highlighted the FDA’s recent actions in clearing over 100 devices designed using 3D printers.