Food & Drug Administration chief Dr. Margaret Hamburg told a gathering of medical device industry leaders that her agency’s plan to revamp the 510(k) clearance process will take account of any "substantive concerns" raised during a public comment period.
"We are really undertaking a serious, thoughtful process of review of all the comments as we shape the process," Hamburg said in a speech at the annual AdvaMed MedTech conference in Washington, D.C. "As we go forward, there will be still be opportunities for comment, feedback, discussion and shaping."
The 510(k) process, by which most medical devices are approved, is under scrutiny from within and without the agency. The FDA is conducting its own review along with a $1.3 million, FDA-commissioned report from the Institute of Medicine.
The protocol relies on so-called "predicate devices," or products the agency has already cleared. Device makers must prove that their new device is an advancement on similar devices the agency has already approved for market. Devices that are radically different must undergo the more rigorous, and expensive, pre-market approval process.
Hamburg, who did not take questions following the speech due to an “unexpected meeting,” said the federal watchdog agency plans to release a summary of the comments it’s received, flagging the recommendations it plans to put in place.
"If substantive concerns were raised about a particular recommendation that we plan to adopt, we’ll explain why we are moving forward," Hamburg said. "As for the rest of the recommendations that sparked significant substantive concerns, we’ll refer them to the IOM for consideration. We hope to make this information public by the end of this year."
Yesterday, Centers for Medicare and Medicaid Services chief Dr. Donald Berwick told the AdvaMed crowd that the healthcare reform act is a growth opportunity for the industry.