The subject of the reliability of the 510(k) process has devoured thousands of hours inside and outside of FDA and gallons of ink in the print media, but a recent report commissioned by the Advanced Medical Technology Association (AdvaMed; Washington) suggests that widespread reports of "disastrous" device clearances are overblown. (Medical Device Daily)

Negotiations between industry and FDA are about to commence for the next round of medical device user fees, but the process for this round is already different from that of the first two iterations in that the agency held a public meeting on the subject. Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, advised attendees that review times for 510(k) filings may be affected by the ongoing restructuring of the device clearance process, but he also said the agency is interested in feedback from all stakeholders, one of which argued that user fees are too low. (Medical Device Daily)

WASHINGTON – A dyed-in-the-wool skeptic might have reflexively chortled when proponents of healthcare reform claimed the changes in the Patient Protection and Affordable Care Act of 2010 (PPACA) would lower healthcare spending, but the skeptics found ammunition in a presentation made Wednesday by actuaries from the Centers for Medicare & Medicaid Services (CMS). The session, held at the National Press Club (Washington) and sponsored by the healthcare policy journal Health Affairs, disclosed that CMS expects healthcare spending to increase the federal deficit by 2019, not reduce it as was commonly claimed during the run-up to reform. (Medical Device Daily)

FDA will probably never get any credit for being the fastest-responding of all federal agencies, and the announcement yesterday that it will reclassify some coronary artery catheters from class III to class II did nothing to dispel doubts about the agency's responsiveness to advisory panel recommendations. (Medical Device Daily)

Companies that offer to test a customer's genome for propensities toward disease states are still offering their services despite a threat from a leading congressional Democrat to shut them down, and all indications are that regulatory bodies see the issue as less than critical despite comments heard from the congressional panel in a July hearing. (Medical Device Daily)