New Developments in FDA Regulation of AI have been announced on Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. Artificial intelligence (“AI”) can be broadly defined as a device or product that can imitate intelligent behavior.
In the health care space, this could include a machine learning algorithm that evolves and improves as new data inputs are entered. This type of adaptive algorithm can provide physicians with diagnostic information for numerous medical conditions.
- Operon Strategist is a medical device consulting company which provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.
- Operon Strategist provides medical device process validation to manufacturers & medical device process validation service providers for the validation activity & documentation
While AI-based medical products hold tremendous potential, the question of their regulation has challenged the U.S. Food and Drug Administration (“FDA”). At issue are the medical device provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which were initially crafted to address medical devices existing in the mid-1970s when the Medical Device Amendments were enacted. These types of products were mostly hardware based, and iterative technology design changes were relatively infrequent.
So, how is the “organization’s excellence” reviewed and qualified? The FDA outlines a two-fold approach that seeks to:
- Assure the usage of Quality Systems and Good Machine Learning Practices (GMLP) by the organization, and
- Assure the usage of SaMD Pre-Specifications (SPS) describing the modifications and Algorithm Change Protocol (ACP) processes to achieve the changes and control the risks.
These approaches work together to determine the level of FDA review required for new modifications. As an example, a change that solely increases performance, is consistent with the SPS, utilizes existing ACP, and did not change intended use or inputs could be made without additional FDA review.
New Developments in FDA Regulation of AI
AI is different from other medical devices, due in part to the fact that AI learns on the job. The fact that such learning changes performance over time and the fact that the company might make frequent updates both suggest the need for a new regulatory approach.
1. Scope Of FDA Regulation Of Medical AI
FDA has been working to clarify what software is regulated and what is not. The most recent phase of those efforts began in December 2016 when Congress passed the 21st Century Cures Act (Cures Act), section 3060(a), which modified the definition of a medical device in the Food, Drug & Cosmetic Act.
The 2016 amendments laid out several categories of software that Congress excluded from FDA regulation. A year later, in 2017, FDA started to implement that legislation by publishing a few draft guidance’s, including one on Clinical and Patient Decision Support Software.
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