How Is AI Optimizing Different Aspects of FDA Submissions?

The Department of Health and Human Services Regulatory agency is known as The Food and Drug Administration. The FDA is accountable for protecting and promoting public health through controlling and supervising food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, and medical devices. FDA approval is a must for any drug to be on the market. FDA plays a crucial role in reviewing drugs, medical devices, and biologics before it enters the market.

The development of pharmaceuticals is a complex and lengthy process. Companies abide by the regulatory body’s guidelines for the effectiveness of the drugs, vaccines, biologics, and medical devices, for which FDA submission is essential and crucial in several steps. Nowadays, companies are leveraging artificial intelligence for effective and quick submissions. The FDA is also developing a new regulatory framework to promote innovation and support AI-based technologies.

A New Strategy of the FDA in Leveraging AI:

·         In 2017, the FDA announced a ‘Digital Health Innovation Action Plan’ to outline its strategy to implement useful healthcare technologies and promote AI-based applications in research and development. Furthermore, the FDA is encouraging initiatives to develop and implement advanced predictive models in streamlining the drug review process. With an adequate regulatory framework, safe and effective therapies can be discovered, developed, and marketed much faster than ever.

·         Traditionally, the FDA evaluates medical devices through a suitable premarket pathway, such as De Novo classification or premarket approval. The FDA may also analyze and clear modifications to medical devices, including software as a medical device, depending on the importance of risk posed to patients by that modification. Learn the current FDA guidance for a risk-based approach for 510(k) software modifications. The FDA’s traditional medical device regulation paradigm was not intended for adaptive artificial intelligence and machine learning technologies. Under the FDA’s current approach to software changes, the FDA anticipates that many artificial intelligence and machine learning-driven software modifications to a device need a premarket review.

·         On April 2nd, 2019, the FDA issued a paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback.” This explains the FDA’s foundation for a possible way to premarket review for artificial intelligence and machine learning-driven software modifications.

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