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Podcast: State Taxation of Digital Health Products
Jones Day Talks Health Care & Life Sciences: What Digital Health Innovators Should Know about the FDA Approval Process
Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more
The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more
On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control Plan (PCCP) in a marketing...more
On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more
Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness...more
In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance. The guidance document is...more
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments."...more
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions...more
On November 3, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance, Content of Premarket Submissions for Device Software Functions, a significant publication that has the potential to impact a variety...more
On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the...more
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more
In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently...more
Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more
On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses...more
Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more
On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that...more
On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020). On October 16, 2020, the US District Court for the Northern District of California granted a motion for summary...more
The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software...more
The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more