News agencies reported that the US Food and Drug Administration (FDA) has chosen three products designed to treat patients with end stage renal disease (ESRD) to be included in the FDA’s Innovation Pathway program, meant to aid in patients receiving effective medical devices in a safe, timely and collaborative manner.
The products were chosen from a total of 32 products that were submitted in response to an open request from the FDA’s device center in January. The three products include an Implantable Renal Assist Device (IRAD), developed by the University of California at San Francisco, a Wearable Artificial Kidney (WAK), developed by Blood Purification Technologies Inc, and a Hemoaccess Valve System (HVS) designed by CreatiVasc Medical. The agency noted that the majority of submission originated at small, start-up businesses and academic institutions.
Director of the Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, MD, said, “The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction.”
These ESRD products will be the FDA focus in the Innovation Pathway program, looking for ways to shorten the time and cost required of developing, assessing and reviewing medical devices, particularly breakthrough devices. The FDA has chosen to focus this round of the Innovation Pathway on ESRD because more than half a million Americans currently suffer from the disease. The program is meant to strengthen the collaboration between the FDA and innovators early in the development process, in order to increase the efficiency and timeliness of the approval process.
As a Harrisburg personal injury attorney, I’m glad to see that agencies and innovators are focusing on more efficient and timely ways in which to product medical devices that are overall safer for patients. If you’ve suffered adverse health effects through the use of a defective medical product, it could be in your best interests to talk to a York personal injury lawyer.
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