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Digital Health › Regulatory Requirements › Regulatory Oversight

Sheppard Mullin Richter & Hampton LLP

What to Watch: WHOOP Warning Letter

Sheppard Mullin Richter & Hampton LLP on

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more

Holland & Knight LLP

Podcast - Regulating AI in Healthcare: The Road Ahead

Holland & Knight LLP on

In this episode of "Counsel That Cares," Public Policy & Regulation attorney John Vaughan, Healthcare attorney Dan Silverboard and Public Affairs Advisor Sarah Starling Crossan discuss the rapidly evolving landscape of...more

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

Hogan Lovells on

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

Gardner Law

Are FDA Review Timelines Slipping? What Companies Need to Know

Gardner Law on

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

Rothwell, Figg, Ernst & Manbeck, P.C. on

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Morgan Lewis

How New Executive Orders May Affect FDA’s Medical Device Operations

Morgan Lewis on

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

McDermott Will & Schulte

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Schulte on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

McDermott Will & Schulte

Three Tips for Tackling Risk in Digital Health

McDermott Will & Schulte on

Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital...more

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