Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. This was followed last September with warning letters issued to two Chinese …
In the past three months, FDA has released two guidance documents related to artificial intelligence (AI) enabled medical devices: (1) a final guidance titled Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (PCCP Guidance, which we blogged about …
The American Conference Institute’s popular “FDA Boot Camp” – now in its 43rd iteration – is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY . The conference is billed as the premier event to provide folks …
As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. FDA requires a new 510(k) clearance when a modification to …
The multi-decade battle over FDA’s power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association …
The government is currently funded through March 14th, 2025. Come Monday March 17th, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities. …
FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). The final guidance hasn’t changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required …
In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). FDA has issued discussion papers (see our posts here and here ) and guidance on use of Pre-determined Change Control Plans …
This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these “lessons” will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. Although FDA has long taken the …
FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. We previously discussed the Third Party Review Program in a blog post last year when FDA …
We recently blogged on FDA’s draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate biocompatibility of a medical device as an alternative to conducting certain biological testing. We noted that the draft guidance’s …
On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr., for Secretary of Health and Human Services (HHS). Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated …
The word unprecedented has been used a lot in the past two weeks. Perhaps appropriately. Below is some precedent that’s been on this blogger’s mind recently and that may be relevant in the coming days, weeks, and months: Tummino v. Hamburg. Why? The HHS Secretary …
“An open foe may prove a curse, but a pretended friend is worse.” When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA was likely the furthest thing from his mind. That he is now being …
In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Sometimes, though, the question of classification defies an easy answer. When a company is unsure if its product is a device, …
