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Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Nelson Mullins Riley & Scarborough LLP

FDA Concludes Software Pre-Cert Pilot Program, Noting Federal Legislative Action is Needed

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more

McDermott Will & Schulte

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

McDermott Will & Schulte on

On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more

Faegre Drinker Biddle & Reath LLP

Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

Faegre Drinker Biddle & Reath LLP on

Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...more

Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed

Butler Snow LLP on

What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more

McDermott Will & Schulte

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

McDermott Will & Schulte on

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...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

Hogan Lovells

FDA releases working model for Software Precertification Pilot Program

Hogan Lovells on

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

Stinson LLP

FDA Issues Guidance on Digital Health

Stinson LLP on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Fenwick & West Life Sciences Group

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

Fenwick & West Life Sciences Group on

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

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