http://www.devicelink.com/transformingfda Just another WordPress weblog Thu, 08 Oct 2009 17:10:07 +0000 http://backend.userland.com/rss092 en FDA has published a draft guidance titled Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses. It contains recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices intended for detection or detection and differentiation ... http://www.devicelink.com/transformingfda/?p=209 There is no timeline yet for doing it, but FDA still intends to regulate laboratory-developed tests (LDTs) under FDA “enforcement discretion,” CDRH acting director of chemistry and toxicology devices Courtney Harper told the RAPS annual meeting audience in September. LDTs are presently marketed under the Clinical Laboratory Improvement Amendments (CLIA) ... http://www.devicelink.com/transformingfda/?p=205 While FDA’s new leadership touts the importance of exemplary science at the agency, a 47-page petition seeking the reconsideration of the agency’s August 4 final rule on mercury-containing dental amalgam trashes the science FDA used in it. The petition also alleges a selective literature search and says that the agency’s ... http://www.devicelink.com/transformingfda/?p=203 FDA has issued a Strategic Plan for Risk Communication, outlining the agency’s efforts to release more meaningful public health information. The plan lays out a framework for FDA to provide information about products to healthcare professionals, patients, and consumers. It also outlines how the agency oversees industry communications. The ... http://www.devicelink.com/transformingfda/?p=200 Former CDRH director Dan Schultz had this to say when reflecting on his tenure at the center's helm: “When I look back over the last five years, I see many CDRH accomplishments to reflect on and many unfinished tasks still ahead. The implementation of device user fees with its influx of ... http://www.devicelink.com/transformingfda/?p=196 The Associated Press has reported that Daniel Schultz, head of CDRH, is resigning his post. In a letter to agency staffers, Schultz said that he and FDA Commissioner Margaret Hamburg agreed that his resignation “would be in the best interest of the center and the agency,” according to the Associated ... http://www.devicelink.com/transformingfda/?p=190 FDA has concluded that dental amalgam fillings are not a health hazard. The agency reached this conclusion after a six-year review of hundreds of studies on the fillings. What makes FDA's position a little puzzling is the fact that just last year, CDRH issued a new policy statement that recognized ... http://www.devicelink.com/transformingfda/?p=187 Construction of CDRH's new facility was recently completed, and now the entire staff is ready to move in. The address of FDA's White Oak campus in Silver Spring is below: 10903 New Hampshire Ave., Silver Spring, MD 20993 CDRH began the move two months ago, and all staff should be located ... http://www.devicelink.com/transformingfda/?p=177 Construction on CDRH's new facility in Silver Spring, MD, has been completed three months early. It marks the third building completed at FDA's Silver Spring campus in the past five years (the other two: the $89.2 million, 573,261-sq-ft CDER building and the $42 million, 123,000-sq-ft central shared use facility). The $93.7 ... http://www.devicelink.com/transformingfda/?p=173 CDRH's Daniel Schultz told attendees at the Medical Device Manufacturers Association annual meeting that FDA and industry have not done a very good job of communicating to the public that the 510(k) process is not the “mindless rubberstamp that some people are making it out to be.” You can read ... http://www.devicelink.com/transformingfda/?p=169