The FDA has finalized a 2018 draft rule that excludes several digital products from the definition of a medical device, a list that includes medical device data systems (MDDS) used in hospitals. The rule responds to requirements spelled out in the 21st Century Cures Act, which was signed into law in late 2016, making this a project of nearly five years’ duration on the FDA’s part.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT.
If the FDA follows the advice of its Cellular, Tissue and Gene Therapies Advisory Committee, the U.S. could soon see its first approved islet transplant therapy, but few expect it to be broadly used. The adcom voted 14-9 April 15, with one abstention, that Celltrans Inc.’s donislecel, or cadaveric allogenic pancreatic islet cells, has an overall favorable risk-benefit profile for some patients with type 1 diabetes.
Just six weeks after receiving FDA 510(k) clearance for its optical coherence tomography (OCT) imaging system (v2.1), Perimeter Medical Imaging AI Inc. received breakthrough device designation from the FDA for its next-gen product, the OCT imaging system with integrated artificial intelligence (AI).
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reverses HHS premarket notification exemptions; ITC will check findings for Zimmer/Heraeus dispute.
The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.
The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE needs more evidence for Clarity RMS for AKI; Thermacor disposable sets recalled.
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will be venturing into new territory April 15 in which it not only has to consider whether the benefit of Celltrans Inc.’s donislecel is clinically meaningful, but it also will have to define the indication.
The FDA and the CDC have jointly recommended a temporary pause in the further rollout of Johnson & Johnson Co.’s COVID-19 vaccine while they investigate six rare clotting cases in adults ages 18 to 48.
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