News
Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
Publications
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News
FDA device software premarket submission content guidance re-categorizes documentation requirements
26 June 2023
The U.S. Food and Drug Administration (FDA) recently issued the final guidance, Content of Premarket Submissions for Device Software Functions, which provides an updated framework by which...
News
The next era of digital therapeutics
16 May 2023
Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has ...
News
FDA promotes pre-approval for changes to AI devices via Predetermined Change Control Plans
12 April 2023
On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change ...
Insights and Analysis
U.S. FDA regulatory insights: the seemingly shifting landscape of clinical decision support
06 March 2023
Clinical decision support (CDS) software has lately been a focus of discussion between FDA, industry, and other interested parties. CDS tools assist clinicians by analyzing patient data and ...
News
FDA to regulate more AI & software tools as devices, guidance indicates
11 October 2022
In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,”...
News
FDA launches list of AI and machine learning-enabled medical devices
23 September 2021
Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S....
News
After a long and winding road, FDA finalizes much-debated “intended use” rule
05 August 2021
On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...
News
HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process
20 April 2021
On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical ...
