Regulatory
timelines, costs, evidence-generation requirements and compliance measures can expedite digital health product clearance and market entry. It can also enable products to qualify for certain additional reimbursement pathways, thus leading to market access impacts downstream, increased product acceptance, and improved patient outcomes. A key step to building a regulatory strategy is classifying the digital health product’s target market, product claim, and benefit-risk profile. This will determine the appropriate level of regulatory oversight the product will be subject to. To provide manufacturers with regulatory pathway clarity and enable greater commercial success, DiMe partnered with industry experts in a pre-competitive collaboration called Digital Health Regulatory Pathways. This multi-sector collaboration brought together experts from academia, clinician associations, tech and pharmaceutical companies, as well as the FDA, to develop a suite of 50-plus resources that directly support innovators who are seeking to optimise their regulatory strategy.
Navigate, don’t speculate The recently launched, interactive, open access U.S. RegPath Tool enables manufacturers to adeptly navigate the intricate US digital health product regulatory pathways, guidelines and regulations. The RegPath’s five-step approach aids manufacturers in classifying their digital health products in the US through tools such as the product categorisation guide, the product classification map and a risk-based assessment model to help manufacturers ensure that products are developed and launched successfully, with any issues being addressed in a timely and effective manner.
As part of the interactive tool, manufacturers initiate the process by answering a few questions about their product to determine if it qualifies under an existing FDA regulatory pathway. If the product – in full or in part – is regulated, the tool identifies for manufacturers how they can identify its function, product class, and optimal regulatory pathway. Additionally, once manufacturers identify the proper regulatory pathway, they have access to toolkits that contain resources related to initiating the appropriate application.
For example, if users learn that their product is likely to undergo FDA’s 510(k) pathway, the toolkit contains resources related to the 510(k) pathway at-a-glance, a 510(k) preparation guide, a 510(k) checklist, and an FAQ document to help manufacturers navigate critical next steps. The U.S. RegPath Tool also features the Library of Digital Health Regulations, a crowdsourced library of US regulations and guidelines that apply
Medical Device Developments /
www.nsmedicaldevices.com RegPath Flowchart
Manufacturers can access a non-interactive version of the U.S. RegPath Tool through the U.S. Regulatory Pathways Flowchart. To optimise flowchart navigation, manufacturers should aim to answer these five questions: ■Who: is the end user of the product? ■What: does the product intend to do? ■When: should the end user utilise the product? ■Where: will the product be used? ■Why: should the end user use the product?
to digital health clinical research and clinical care products. The library enables manufacturers to efficiently filter and search through various US regulations and guidance. Over the next year, additional resources will continue to be added to the collection to help manufacturers pursue and optimise their regulatory, evidence generation and business strategies across multiple global markets and regions.
A well-thought-out regulatory strategy can proactively demonstrate a product’s safety, effectiveness, and quality to patients, clinicians, and payers. Tidepool Loop, for example, is a closed- loop automated insulin delivery system intended for the management of type 1 diabetes. The product received 510(k) clearance from the FDA in January 2023, but prior to then, patients used DIY looping instead of an FDA-cleared product when they needed to automate insulin delivery and reduce the burden of type 1 diabetes. Tidepool created a strategy to build a product that delivers an FDA-regulated version of the unregulated DIY Loop app(s), thus making it broadly available for patients to download via the iOS App Store. Receiving a 510(k) clearance, Tidepool Loop became recognised as a Class II medical device and the first fully interoperable automated insulin dosing app intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps. These technologies work in tandem to automatically increase, decrease and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.
Evolve strategy as products evolve Products will continue to evolve and iterate even after manufacturers build their initial regulatory strategy. Manufacturers therefore face the question of whether products need to go through the full regulatory process again, versus following an expedited pathway, or not. A good regulatory strategy accounts for future product iterations and changes from the outset. Take for example, Caption Health’s Guidance software, the first cardiac ultrasound software intended to assist medical professionals in the
19
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 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146
