On Tuesday, May 6th, the Circulatory System Devices Panel of the Medical Device Advisory Committee provided favorable.
On Tuesday, May 6th, the Circulatory System Devices Panel of the Medical Device Advisory Committee provided favorable recommendation to the FDA of the RESQCPR System for use in the performance of CPR to increase the likelihood of survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during CPR in an attempt to enhance venous return to the heart and blood flow to vital organs.
The panel voted unanimously that the device is safe, and a majority agreed that the benefits of the RESQCPR System outweigh the risks for the device’s proposed indications. While some of the members of the panel questioned the effectiveness of the device, several members of the panel explained their positive vote on risk-benefit profile by stating that there was a strong “signal” of effectiveness and indicated that this should be studied in a post-market setting. The panel also discussed the complexity of performing cardiac arrest research and the need to find solutions to improve survival of the nation’s third leading cause of death – cardiac arrest. The CEO of Advanced Circulatory, Mike Black, stated “We appreciate the positive feedback of the panel on the safety and risk-benefit profile of the RESQCPR System. We look forward to working with the FDA to take the panel’s recommendation into consideration and complete the next steps required to approve the RESQCPR System.”
The agency is not obligated to follow its panel’s recommendation, but normally does so.
Session II of this meeting of the Circulatory System Devices Panel, originally scheduled for Wednesday, May 7th, has been postponed.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us