To support the continuation of the development and marketing of safe and effective medical devices promoted by artificial intelligence, the US Food and Drug Administration will provide marketing recommendations, including the necessary documents and information during the total product life courses for the organizational control and effectiveness control, on Tuesday.
Why do it matter
After its issuance last month from Prospects of the pre -defined change plan to provide artificial intelligence offers and machine learning – Determining what is required to maintain the components of artificial intelligence/ml and clarify that in order to organizational review without operating a completely new marketing submission – The Food and Drug Administration provides developers of medical devices with the product design and the development and main documentation of initial introductions.
The guidance that will be It was published in the federal registry On January 7, it will be the first to provide the recommendations of the total product life cycle of devices that support artificial intelligence, and link all design, development, maintenance and documentation recommendations, so when the FDA ends in its advertisement on Monday.
The agency generally said that it encourages developers and innovators to get involved early and often to direct activities during the agency’s life cycles – planning, development, testing and continuous monitoring.
After declaring more than 1000 devices AI is enabled through the pre -shopping paths in place, the FDA collected the requirements, in addition to learning the joint agency to be “the first reference point for specific recommendations that apply to these devices, from the early stages of said Toy Tazbaz, The director of the Excellence Center at the Food and Drug Administration Center (FDA) in a statement, in a statement that the development through the entire life cycle of the device.
The agency said that the new guidance will address strategies that address transparency and bias, with specific advice to show the management of prejudice risks, design suggestions and studied evaluation.
The FDA (FDA) said that it will accept public comments on the draft guidelines until April 7 and specifically request comments on the alignment of the life of artificial intelligence, the adequacy of artificial intelligence recommendations, the performance monitoring approach and the types of information that should be transferred to artificial intelligence users of medical devices.
CDRH said it would also host Seminars online On February 18 to discuss her new organizational proposal and on January 14th on Final PCCPS instructions Released in December.
The biggest direction
in Blog Tazbaz Cowrote last year with John Nicole, a digital health specialist in the FDA, the principles of life cycle management can help the mobility of complications and risks associated with the artificial intelligence program in health care.
Since artificial intelligence is constantly learning and adapting to real world settings, the ability to adapt to great risks, such as exacerbation of data or algorithms, and may harm patients and more unlimited populations. ”
To address advanced risks in organizing medical devices that support artificial intelligence, FDA sought for the first time to PCCPS for AI/Ml devices.
“The approach proposed by the FDA (FDA) in this guidance project would ensure that important performance considerations, including race, race, intensity of illness, gender, age, and geographical considerations, are addressed in continuous development and verification of the health and monitoring of artificial intelligence/ said deputy. The director at the center Brendan Olieri at the center.
In the record
“While we continue to see exciting developments in this field, it is important to realize that there are unique specific considerations of devices that support artificial intelligence,” Tazbaz said in a statement.
Andrea Fox is a great health care editor.
Email: Afox@himss.org
Healthcare is Hosz News.
