Sher Quoted in MedTech Dive on Regulation Outlook for 2023

Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore
– MedTech Dive

Manatt Health Partner Rachel Sher was quoted in MedTech Dive on what regulatory challenges may await medical device makers in 2023. 

In the wake of the pandemic, digital health surged, with a rise in applications for review and the emerging role of AI and machine learning. In the article, Sher was among a number of industry observers who gave perspective on the regulatory landscape for the medtech field in the coming year. 

Sher’s take: “Congress has spoken: FDA and medical product sponsors must make more progress toward the goal of ensuring better participation in clinical trials by diverse and underserved populations. The Food and Drug Omnibus Reform Act of 2022 (FDORA) established a new requirement that all marketing applications for medical devices and drugs include a “diversity action plan” detailing the ways in which sponsors will meet specified enrollment goals.  

“The COVID-19 pandemic underscored the promise that decentralized clinical trials hold in helping to foster greater clinical trial participation by all patients. The continued success of the decentralized clinical trial model relies on more and better use of digital health technologies, like smart and wearable devices. As these technologies evolve, FDA must continue to iterate on the guidance it has issued to date to ensure that developers in this space can speed products that meet FDA’s standards to patients and all of those engaged in the clinical trial enterprise.” 

Read the full MedTech Dive article here



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