search.noResults

search.searching

saml.title
dataCollection.invalidEmail
note.createNoteMessage

search.noResults

search.searching

orderForm.title

orderForm.productCode
orderForm.description
orderForm.quantity
orderForm.itemPrice
orderForm.price
orderForm.totalPrice
orderForm.deliveryDetails.billingAddress
orderForm.deliveryDetails.deliveryAddress
orderForm.noItems
Regulatory


It’s fi nally here: the FDA’s action plan for regulating medical devices employing AI/ML. Monica Karpinski investigates the key legal, practical and ethical challenges the FDA needs to address, asking what the eventual regulations may look like and how manufacturers can use them to improve the way they work with AI devices.


n October 2014, Elon Musk famously likened


the use of AI to summoning a demon. He was no doubt referring to the existential threat of using technology that is unknowable: if it changes in ways


n October 2014, Elon Musk famously likened the use of AI to summoning a demon. He was no doubt referring to the existential threat of using


technology that is unknowable: if it changes in ways that we can’t predict, how can we hope to control


Now, regulators are asking themselves the same questions. Recent years have seen global


In January 2021, the FDA released an action plan describing how they mean to establish a


In January 2021, the FDA released an action


plan describing how they mean to establish a regulatory framework for medical devices that


that we can’t predict, how can we hope to control it? How can we guarantee that it will be safe to use?it? How can we guarantee that it will be safe to use? Now, regulators are asking themselves the


same questions. Recent years have seen global recommendations put in place for regulating AI, but


recommendations put in place for regulating AI, but it is very much an emerging field – many agenciesit is very much an emerging field – many agencies are still in the research phase of developing clear and defined guidelines.


are still in the research phase of developing clear and defined guidelines.


regulatory framework for medical devices that use AI. While this is an exciting step forward, s only the beginning of the journey. The


use AI. While this is an exciting step forward, it’it’s only the beginning of the journey. The plan should be understood as a statement of


Affirmative action I


plan should be understood as a statement of intentions – a road map towards an enforceableintentions – a road map towards an enforceable set of rules. As such, the plan explains how the


set of rules. As such, the plan explains how the agency will proceed with investigating five key


agency will proceed with investigating five key areas relating to software as a medical device


areas relating to software as a medical device (SaMD): creating a regulatory framework for


(SaMD): creating a regulatory framework for devices that change over time, establishing best


devices that change over time, establishing best practices in AI/ML, fostering a patient-centred


practices in AI/ML, fostering a patient-centred approach, managing algorithmic bias and


approach, managing algorithmic bias and robustness, and monitoring real-world performance


Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based


Artificial Intelligence/Machine Learning-Based Software as a Medical Device’.


robustness, and monitoring real-world performance of devices. It is informed by stakeholder feedback


of devices. It is informed by stakeholder feedback on a 2019 FDA discussion paper entitled, ‘Proposed


Software as a Medical Device’. The work that has already been done to assess


some clues on how the action plan is likely to be used and refined. By considering how the legal,


used and refined. By considering how the legal, ethical and practical challenges identified could


on a 2019 FDA discussion paper entitled, ‘Proposed Regulatory Framework for Modifications to


The work that has already been done to assess and regulate the use of AI in medical devices gives


and regulate the use of AI in medical devices gives some clues on how the action plan is likely to be


ethical and practical challenges identified could realistically be addressed, it’s possible to get a sense of what the eventual regulations will look like.


realistically be addressed, it’s possible to get a sense of what the eventual regulations will look like.


28


Medical Device Developments / www.nsmedicaldevices.com


Andrey_Popov/Shutterstock.com


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133