Novel kidney dialysis devices will be available to patients faster, under a new plan launched by the U.S. Food and Drug Administration (FDA) designed to respond to medical innovation.
The program, “Innovation Pathway,” aims to reduce the time and cost of bringing safe and effective breakthrough technologies to patients, FDA says in a press release. The approach is intended to deepen collaboration between FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory and product development process more efficient and timely, the agency says.
FDA chose three kidney dialysis technologies from 32 applicants as part of the pilot program that will expand to other device companies and medical conditions, reports Anna Yukhananov for Reuters. The three devices replicate the function of the kidneys. She writes:
One of the three technologies, from the University of California, San Francisco, combines a dialysis device that is implanted in the gut with live kidney cells. A second device, from Beverly Hills, California-based Blood Purification Technologies, Inc, is a wearable artificial kidney. The third, a Hemoaccess Valve System made by Greenville, South Carolina-based CreatiVasc Medical, modulates blood flow between dialysis and regular kidney functions.
The program will give companies with innovative technologies more opportunities to meet regulators and scientific experts to explain what their devices do and prove that they are safe before they begin testing on patients. This process will not only speed up approval but help regulators better understand new technologies that they may not be familiar with.
“The problem is that very often there are no precedents,” says Jack Lasersohn, a venture capitalist with the Vertical Group, who consulted with the FDA on the program. “When you go to the FDA with a new type of technology, you’re raising regulatory and fundamental scientific questions that the FDA has never seen before.”
The new approval procedure could shorten the time it takes to develop a clinical trial program by six months to a year, Lasersohn says. Typically, it takes four to seven years to bring new technologies to patients from the time they are designed.
Consumer groups, on the other hand, argue that the FDA should take a more rigorous approach to testing devices to avoid safety failures. They pointed to recent issues with metal-on-metal hip implants and surgical mesh.
Source: “FDA Program to Foster Innovation Starts with Kidneys,” Reuters via The Columbus Dispatch, 4/9/12
Source: “FDA Announces Plans to Pilot End-Stage Kidney Disease Technology in New Program,” FDA press release, 4/9/12
Image by C_Oliver, used under its Creative Commons license.
Dale McGeehon has been a journalist and editor for more than 25 years, covering chemical regulation and testing for Pesticides and Toxic Chemical News and innovations in material sciences for the National Technology Transfer Center. His writing credits include Omni and College Park magazines and The New York Times.