FDA Proposed Rules Address Industry, Consumer Concerns

The Food and Drug Administration may tighten rules for approving medical devices that are only slightly different from already-blessed products, The Chicago Tribune reports. "One trigger for the agency's review was a case involving Dr. Patrick McCarthy, a cardiac surgeon at Northwestern Memorial Hospital who implanted into patients a heart valve repair ring made by California-based Edwards Lifesciences. Two of the patients filed suit, claiming permanent injury. Both said they were unaware the heart ring was different from FDA-approved versions." Even as the FDA revamps its rules, it says it will not pursue action against the firm, the surgeon or the hospital because all made a "'good faith effort' to comply" with ambiguous rules (Shelton, 8/4).

Indeed, Bloomberg reports, "[m]edical device companies say the 510(k) process" - for approving similar devices - "is rife with delays and inconsistent requirements, while consumer advocates say patients are at risk because of inadequate safety rules. The new proposals address both issues, giving device makers a more predictable process while insisting they provide more safety data, said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health." The agency has released new proposed rules for the process earlier this week. Under the rules, device makers will be required to provide the FDA with more safety data, among other things (Olmos and Yan, 8/4).

The earlier process only required device makers to prove that the new products were similar to ones already approved for the market, according to the Minneapolis Star Tribune. The new rules would make it more clear which devices need clinical studies, streamline the approval process for new, low-risk devices, set up new channels of communication between industry and regulators and increase the science training of FDA staff (Moore, 8/4).