FDA: Medtronic, CardioMEMS panel reviews are on despite government shutdown

Despite the government shutdown, Medtronic ($MDT) and CardioMEMS will proceed with key FDA meetings scheduled for this week intended to advance approval processes for their medical devices, the agency confirmed.

The agency's Circulatory System Devices Panel is scheduled to meet Oct. 8-9 to consider regulatory signoffs sought by both companies. Some have worried that the government shutdown that kicked in on Oct. 1 would delay those plans and other FDA panel meetings. But an FDA spokesman told FierceMedicalDevices via email that the two-day session will proceed as planned.

"Yes, the meeting is being held," the FDA's Steven Immergut told us.

The panel is primarily filled with experts who don't work for the agency, though FDA experts typically present their evaluation of a given product or device during the all-day session. Panel recommendations for or against a product approval aren't binding, but they influence the FDA's final decision. Depending on how long the government shutdown lasts, an open question will be whether the shutdown delays final FDA approval or clearances of devices and diagnostics now in the pipeline.

Medtronic is scheduled to appear before the panel on Oct. 8 to make its case for expanded indications for its Cardiac Resynchronization Therapy pacemaker and Cardiac Resynchronization Therapy defibrillator devices. As the Minneapolis/St. Paul Business Journal reported, the analyst firm GlobalData predicted that the federal government shutdown would delay the meetings because the FDA presently lacks the resources to prepare.

Similarly, the panel is scheduled to meet Oct. 9 to discuss and make recommendations on CardioMEMS' premarket approval application for the Champion HF monitoring system, an implantable device designed to help guide the treatment of congestive heart failure. CardioMEMS is a private medical device company based in Atlanta, GA.

- here's the FDA's panel meeting agenda
- read the Minneapolis/St. Paul Business Journal's take

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