In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV). As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to …
The recent and drastic Reduction In Force (RIF) at the U. S. Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. While much of the focus has …
Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Regardless of your position on the correctness of the holdings or the reasoning behind …
Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails. According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA …
On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDA’s Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. That Rule sought to codify FDA’s view that LDTs are medical devices subject to FDA regulation under the …
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 …
