Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]
Today, May 22, 2025, “[t]he U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid” (see the FDA announcement here). The two labs receiving the so-called General Correspondence Letters are […]
The 2024 MedTech Conference in Toronto provided some great insights on what the future of medical devices can offer, particularly when utilizing AI technology. One area making great progress is the use of wearables. Who knew my Apple watch could be so useful?! There were multiple presentations on pairing wearable devices with mobile apps. This […]
Reviewed “under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device,” the Agency has approved an OTC software solution that is compatible with certain Apple AirPods Pro headphones and provides, according to the FDA release […]
The FDA’s long-awaited QMSR will be released in February 2026. The amended 21 CFR 820 will incorporate by reference the Quality Management System (QMS) requirements of the 2016 edition of ISO 13485. We will explore the key differences between an FDA inspection and a notified body audit as well as the distinctions between ISO 13485 and the QMSR. […]
Although the FDA’s regulatory requirements for acceptance of vendor test results in lieu of testing is clearly specified in 21 CFR 211.84 for incoming raw materials and container closures, the FDA has not put forth specific regulations for the acceptance of single-use consumables. Biologics manufacturers may use dozens or even hundreds of different single-use consumables […]
The FDA has published its Medical Device User Fees for FY 2025 (here) and the reason there are no surprises is that the fees all went up. The new fees are effective on October 1, 2024. The Federal Register Notice (FR) “provides information on how the fees for FY 2025 were determined, the payment procedures you should follow, […]
FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here). This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023. FDA explains that since “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]
The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, […]
The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule. The FDA states: “We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes. […]
