| Recently, the FDA delivered a speech at the Medical Instrument Promotion Association (AAMI) conference, which outlined its plans in each area. About cyber security. According to reports, the agency has had an update with the industry and healthcare providers on why they need to be updated in 2014. The FDA's Center for Devices and Radiological Health (CDRH) is working hard to formulate new industrial policies and regulations, and further develop existing ones for each of the three topics. Policies and regulations.  Suzanne Schwartz, deputy director of the CDRH Science and Strategic Partnership, emphasized that FDA plans to update the pre-market guidance and the agency is studying how to ensure effective cyber security management. FDA also plans to qualify for more medical device development tools. One - Kansas City Cardiomyopathy Questionnaire (KCCQ) - approved by the FDA. Regarding AI, it was mentioned that the FDA does not have any policies that apply to the continuous learning system. The agency invites stakeholders to provide advice and therefore can define some requirements for AI health products. 3D printing, especially the anatomical model, is also mentioned For the FDA's new area, James Corburn, a senior researcher at CDRH, said: '3D printing is an interesting area because it is a bit different from what the FDA normally does. Patient-oriented 3D printing devices are a new opportunity in a huge area because they can Lower cost to create any geometry. ' Recently, FDA approved Materialise's Mimic inPrint software for preoperative planning. The CDRH staff also highlighted the FDA's recent move to clean up more than 100 devices using 3D printer designs. |
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