Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

A review of public comments on a proposed FDA regulatory framework, for modifications to artificial intelligence and machine learning-based software as a medical device, has found that 63% came from parties with financial ties to industry, and that the majority, 86% did not cite any scientific evidence.

Building with signage US Department of Health and Human Services Food and Drug Administration

The findings come from a cross-sectional study, published in BMJ Open, of the comments submitted to the US Food and Drug Administration (FDA) ‘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’. 

Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care, continually incorporating insights from the vast amount of data generated every day during the delivery of health care. Many such devices must have regulatory approval or clearance before being available for clinical practice, and in the US that regulation falls to the FDA.

The suitability of traditional medical device regulatory pathways for AI/ML have been called into question because the nature of the technology means it is continually evolving and adapting to improve performance. Under the current framework it would mean that as devices evolved they would require further review and approval, which could be time consuming and may affect patient safety and interests. The FDA has therefore proposed a new regulatory framework for modifications to AI/ML and has asked for feedback from the public to refine the regulations.

“The process for developing regulations is, roughly, to get feedback from the public on its initial proposal, make changes and draft regulations or guidance, get more feedback, and eventually finalise,” said James Smith, Postdoctoral Scientist at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford and lead author of the report. “Anyone can comment but at present there is no requirement, or even recommendation, to disclose any conflicts of interest. Also, the FDA states that it looks for ‘good science’ in comments but it is not a requirement to incorporate it. Our goal was to look at the extent and disclosure of financial ties to industry and the use of scientific evidence.”

The team analysed all 125 publicly available comments on the FDA proposal between 2 April 2019 to 8 August 2019 and found that 79 (63%) comments came from parties with financial ties to industry in the sector. For a further 29% of comments the presence or absence of financial ties could not be confirmed. The vast majority of submitted comments (86%) did not cite any scientific literature, with only 4% citing a systematic review or meta-analysis.

The full story is available on the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences website

Similar stories

New reporting guidelines developed to improve AI in healthcare settings

New reporting guidelines, jointly published in Nature Medicine and the BMJ by Oxford researchers, will ensure that early studies on using Artificial Intelligence (AI) to treat real patients will give researchers the information needed to develop AI systems safely and effectively.

Major boost for Oxford’s mission to counter future pandemic threats

The Moh Family Foundation has given a substantial gift to support the work of Oxford University’s Pandemic Sciences Institute, greatly strengthening its ability to identify and counter future pandemic threats and ensure equitable access to treatments and vaccines around the world.

Three NHSBT research units launch at University of Oxford

The NIHR has awarded three new Blood and Transplant Research Units (BTRUs) to the University of Oxford.

Fourth COVID-19 vaccine dose provides stronger immunity boost than third dose, shows UK study

COVID-19 vaccines given as fourth doses in the UK offer excellent boosting immunity protection, according to the latest results from a nationwide NIHR-supported study.

COVID-19’s high blood clot risk

A recent study of patient health records found that around 1 in 100 people with COVID-19 had a venal or arterial thrombosis, with rates higher still among males, and particularly for those hospitalised.

Medical Sciences Division receives REF 2021 results

Today the UK Funding Bodies have published the outcomes of the recent national research assessment exercise, the Research Excellence Framework (REF) 2021. REF is the UK-wide assessment of research in universities, and provides an expert evaluation of the quality of the research outputs, impact and environment at subject level in each university.