The medical device industry is gearing up for Friday, when the Institute of Medicine will recommend how the FDA could tweak its accelerated 510(k) approval process that takes into account both the need for speed and safety. Reuters filed a report outlining the issues involved.
The nonprofit IOM is tackling some difficult issues, with critics saying the 510(k) program leads to approval of inadequately tested medical devices and others saying it is crucial to speed these technologies to patients. The IOM will also recommend whether to create an entirely new category for "risky devices" that would come under more stringent approval requirements.
"Potentially it could have a big impact on how things will be changed," Dr. Gregory Curfman, executive editor of the New England Journal of Medicine, told Reuters of the IOM's report.
The FDA requested that the IOM conduct the review, but some critics are saying that the agency dragged its feet. "Let me say that the whole process is illogical, because the FDA knows best what they need to do," Diana Zuckerman, president of the National Research Center for Women & Families, told Reuters. "And in some kind of ideal world the FDA would have come out with these proposals and implemented them."
- read the Reuters report
- download FierceMedicalDevices' free ebook on the 510(k) revisions
Free eBook: The FDA's 510(k) Initiative