Bill Kitchens Quoted in Pharmawire

Pharmawire published an article in which William H. Kitchens is quoted regarding the FDA-proposed 510(k) guidelines. Over the next two years, the Food and Drug Administration (FDA) will be changing the device clearance process, leading 510(k) device makers to expect delayed market entry and greater clinical data requirements. Two recent FDA reports list proposed changes the 510(k) process in response to growing external and internal pressure to reform the process. One of the key recommendations is to post detailed 510(k) information online, possibly including summaries of FDA review decisions, current labeling and photos. Mr. Kitchens says that this poses a concern for some companies because of the possibility of trade secret revelations. He adds that the specific information the FDA wants to post is unclear, but until revealed, companies need to be cautious. Click here to read the article, “FDA Proposed 510(k) Guidelines Could Spur Delayed Market Entry and Need for More Clinical Data—Experts.”