FDA recently issued a warning letter to Wavi that claimed its AI code used for its Wavi Desktop product was “for research use only” and not subject to FDA regulation. This is not a judgement on Wavi as…Read More
November 4, 2023
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Category: FDA
September 29, 2023
Late Breaking News: FDA Issues Proposed Rule on Laboratory Developed Tests (LDTs), Outlines Plans for Greater Oversight of LDTs and Eventual Phaseout of Enforcement Discretion Approach to LDTs
It has been highly anticipated that FDA was planning to issue a new proposed rule on laboratory developed tests (LDTs) with suggestions that a proposed rule could come in by the end of this week. The expectation clearly…Read More
September 28, 2023
FDA Transition Plan in Action as Demonstrated by Akili EndeavorOTC Product
In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline…Read More
August 24, 2023
Follow-up On AI Enabled Medical Devices with Recent De Novo Classifications
Two devices with recent De Novo Classifications were reported on recently in the Viz.ai HCM and Better Therapeutics devices that employ Artificial Intelligence (AI) and/or Machine Learning (ML). The Classification Order for both were recently published and present…Read More
August 17, 2023
Comments on FDA Draft Guidance Related to Predetermined Change Control Plan for Artificial Intelligence and Machine Learning (AI/ML) Enabled Device Software Functions
It is not often the FDA offers truly transformative guidance to enable industry to constructively advance cutting edge technology in a practical way. But with the draft FDA guidance titled “Marketing Submission Recommendations for a Predetermined Change Control…Read More
January 7, 2016
The New Launchpad for Mobile Medical Device Apps: the Consumer Electronics Show
There was a time not too long ago when medical devices were launched to the world almost exclusively at preeminent medical society meetings, primarily to gain the focused attention of physicians and/or other medical professionals who may use…Read More
October 29, 2015
Theranos and the FDA: A Cautionary Tale on the Need for Regulatory Strategy
A flurry of recent reports in the Wall Street Journal, New York Times, Forbes and Reuters regarding Theranos states it is using an unapproved medical device, not adequately following up on customer complaints and suffers from other quality control deficiencies.…Read More
May 24, 2015
What does FDA intend to regulate and what does that mean for my digital health product?
The FDA issued final guidances applicable to digital health products on mobile medical applications (MMA) and medical device data systems (MDDS) in February 2015 and a draft guidance on general wellness products (GWP) in January 2015. The MMA…Read More
