How Is AI Optimizing Different Aspects of FDA Submissions?

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• 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 bodys 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 FDAs
  traditional medical device regulation paradigm
  was not intended for adaptive artificial
  intelligence and machine learning technologies.
  Under the FDAs 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 FDAs foundation
  for a possible way to premarket review for
  artificial intelligence and machine
  learning-driven software modifications.

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