There are some U.S. FDA work items that have been hampered primarily by the COVID-19 pandemic, and some that have just proven difficult to push across the finish line. The FDA’s October 2018 draft guidance for premarket considerations for cybersecurity in medical devices might fall into that latter category, but the FDA’s Suzanne Schwartz said the agency will reissue another draft version of that guidance, which will be available sometime in early 2021.

The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.

Biosense Webster Inc. reported U.S. FDA approval of its Thermocool Smarttouch SF ablation catheter for the treatment of patients with persistent atrial fibrillation (persistent AF). This follows results of the prospective, multicenter Precept study, which showed the catheter to be safe and effective for 80% of patients over 15 months of ablation therapy with clinically meaningful improvement in quality of life.

U.S. FDA commissioners must rely on legal counsel for advice on a number of matters, but attorneys who sign on for work at the agency bring with them different views on the limitations of the agency’s powers. This consideration came up during a panel discussion hosted by the Food and Drug Law Institute (FDLI).

The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.

Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.

Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices.

In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.

Medtronic plc’s winning streak continued this week with the announcement that the U.S. FDA had given its nod for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES). The approval is based on results from the Onyx ONE Clear Study that evaluated about 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx.