News & Analysis as of

Food and Drug Administration (FDA) Federal Food Drug and Cosmetic Act (FFDCA) Digital Health

Mintz - Health Care Viewpoints

2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more

MoFo Tech

AI Trends For 2023 - FDA Regulatory

MoFo Tech on

In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program....more

Foley & Lardner LLP

Wondering if Your Digital Health Product or Service is Subject to FDA Regulations?

Foley & Lardner LLP on

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more

McDermott Will & Emery

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

McDermott Will & Emery 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(FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance.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

Nossaman LLP

FDA Policy for Mobile Medical Applications

Nossaman LLP on

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

McDermott Will & Emery

Special Report: FDA 2019 Year in Review

McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

McDermott Will & Emery

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

McDermott Will & Emery 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

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

Jones Day

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

Jones Day on

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more

Akin Gump Strauss Hauer & Feld LLP

New FDA Guidance Clarifies Exemptions for Digital Health Software

• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more

Holland & Knight LLP

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

McDermott Will & Emery

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

McDermott Will & Emery on

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

Holland & Knight LLP

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

Akin Gump Strauss Hauer & Feld LLP

The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions

Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more

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