FDA considers proposals to change medical device approval process

[Justin]

FDA considers proposals to change medical device approval process

The Wall Street Journal (2/18, Mundy, Favole) reported that an internal FDA memo indicated that the agency is considering proposals to change its fast-track medical device approval process called 510(k), which is intended for devices that are similar to products that have already received approval. The memo also raises concerns that device makers are increasingly hiring private companies to pre-review products, which may prevent further FDA scrutiny before the agency approves the device.

The AP (2/18, Perrone) reports that the "510(k) system is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing." The approval process "has drawn scrutiny from the Government Accountability Office, which last year identified 20 types of high-risk devices that slipped through FDA." The agency "has formed an internal panel to review and improve the medical device approval process, and "the FDA will hear from manufacturers, physicians and consumer advocates at an all-day, public meeting Thursday."

Sen. Grassley seeks update from FDA on medical device guidelines. The AP (2/18, Johnson) reports that Sen. Chuck Grassley (R-IA) "is asking the FDA for an immediate update on plans for new guidelines" for new medical devices in a letter released Wednesday. Sen. Grassley "says he's following up on questions he asked more than a year ago, after a star surgeon at Northwestern Memorial Hospital in Chicago implanted a heart device in patients without proper FDA clearance."

[sportsnut3007]

Ok, lets hope this doesnt get the fda bashful on approval of the new stem cell revolutionary stuff coming. I am very afraid this will make this process slower now. Hopefully it doesnt.