The AP reports, “The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices.” Notably, the “agency announced a series of changes it plans to make this year, including streamlining the review process for some low-risk devices,” although “regulators said they will delay a decision on the most drastic proposals, which would give the government new power to police device makers.”
Bloomberg News reports, “While companies say the 30-year-old review program is out-dated and inconsistent, lawmakers have criticized the FDA for not requiring substantial testing of new devices that developers claim are similar to existing products.” The agency “plans to clarify when clinical studies are required and create a council of top FDA experts to guarantee timely and predictable decision-making.” Notably, “about 3,000 new devices are cleared each year through the 510(k) program by demonstrating they are at least as safe and effective as legally marketed products for the same use. These applications rarely require tests in people, and they make up 90 percent of device approvals, according to a Government Accountability Office report in 2009.”
The Hill reports in its “Healthwatch” blog that the “FDA launched a review of the so-called 510(K) process 16 months ago following growing criticism that it is failing both the industry and consumers.” Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA said, “We have been hearing major concerns about the program from industry, consumers, healthcare professionals and others.” Therefore, “these actions are intended to foster medical device innovation and support the safety and effectiveness of medical technologies in the United States.”
Reuters also quotes Shuren as saying that these changes will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.”
The Wall Street Journal says that this move by the FDA is considered a victory for device makers, but the agency is denying that its decision was influenced by pressure from industry and some lawmakers. Shuren said, “We are implementing 47 [changes], and that’s a lot. … We went out with truly bold proposals” last year.
The Minneapolis Star Tribune reports, “The new rules drew a collective sigh of relief from the $350 billion medical technology industry, which has a considerable stronghold in Minnesota. But the activist group Public Citizen fired back that the agency cowed to industry pressKraft
From the American Association for Justice news release.