510(k) Face-Off: CDRH's Foreman Debates Reform Plans With Industry Reps
The 510(k) program and plans by FDA to reform it have caught the attention and anxieties of the device industry. And Christy Foreman's frequent flyer miles have swelled as a result. The acting director of the Office of Device Evaluation within the agency's Center for Devices and Radiological Health (CDRH) has traveled from coast to coast answering questions and attempting to allay concerns about FDA's plans for the 510(k) program, which is used by companies to bring more than 90% of new devices to the US market. In late October, Foreman participated in a panel at Elsevier Business Intelligence's IN3 Summit in San Francisco. There, she joined two other prominent individuals in the industry for a discussion of the 510(k) program and possible impending changes to it.
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For much of the device industry, 2010 felt like a transition year, breeding uncertainty in a number of important areas, including the economy, health care reform, and impending changes to the 510(k) process. A review of the year just ended turns up these stories: Device M&A on the Rebound; Is A First-Mover Advantage Emerging In Medtech? Boston Scientific Is Back In The Game; Early-Stage Deals In Decline; The Future Of Medtech: Where Private Investment Dollars Are Flowing; Transcatheter Valves Take Center Stage; Spine's Downturn; Diabetes Assumptions Begin To Shift; A Landmark Year In Ophthalmology; Health Reform In 2010: A Beginning, Not An End; Changes At FDA: 510(k) Reform Takes Shape, and finally, Is Physician Choice In Product Selection In Danger?
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