Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug and biological products, this time focusing on the use of AI/ML in the drug and biologic development process, “Using Artificial Intelligence &
FDA Releases Draft Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations
On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June 2017 entitled Use of Electronic
FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input
5 Digital Health Issues to Watch at FDA in 2022
As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities. From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in 2022 related to FDA and
FDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.
The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which
Client Alert: FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH
The following guidance could be relevant to manufacturers of software as a medical device (SaMD). The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance
FDA Issues COVID-19 Policy for Certain Digital Health Solutions
On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written policies – to facilitate consumer and patient use and reduce potential exposure to COVID-19. The guidance applies to two groups of products: (1) computerized behavioral therapy devices and other digital health devices for psychiatric disorders; and (2) low-risk wellness and digital health products for mental health or psychiatric conditions. Like FDA’s many other COVID-19 enforcement policies, the policy will remain in effect “only for the duration of the public health emergency related to COVID-19.”
Continue Reading FDA Issues COVID-19 Policy for Certain Digital Health Solutions
The Potential Benefits of Digital Health Technology in Managing COVID-19
The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges. The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19. The Centers for Disease Control
Ideation Question #10: What Are the Priorities for the Solution?
This is the tenth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: What are the priorities for the solution?
Ideation Question #4: What Data Will Be Needed to Substantiate the Offering?
This is the fourth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what data will be needed to substantiate the offering?