Entries in 501(k) (1)


Experts Say FDA Should Abandon Approval Process

Comstock/Thinkstock(WASHINGTON) -- A panel of medical experts said the government should abandon its system for approving most medical devices in the U.S., because it offers patients no assurance of safety.

The U.S. Food and Drug Administration currently uses a streamlined review, called 501(k), to approve products that are similar to those it has already approved. The streamlined review, used for about 90 percent of medical device applications, including those for knee and hip replacement, takes about 10 months, as opposed to the several years a more complex review would take.

The Institute of Medicine said in a report released Friday that the FDA should instead require each device maker to prove that moderate-risk products are safe and effective, and possibly test the devices on actual patients. Last week, the Government Accountability Office said that a staggering 83 percent of 700 devices recalled every year are moderate-risk.

"The 501(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one," states the institute's report.

The FDA said it stands behind the 501(k) approval process because it has helped support a "robust medical device industry in the U.S. and has helped bring lower-risk devices to the market for patients who need them." It will, however, have a public meeting to discuss the institute's recommendations.

The device industry's top lobbying group immediately dismissed the proposal.

"The report's conclusions do not deserve serious consideration from Congress or the administration," said Stephen Ubl, president of the Advanced Medical Technology Association. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure."

Artificial hips and knees are now a nearly $7 billion market, with 1 million people getting either knee or hip surgery every year, according to several reports. Many of those patients, however, have had to endure second surgeries, because the devices already inside them were faulty.

Patients are urged to ask their doctors if they are paid by the maker of the implant they're recommending. Patients are also encouraged to check the device maker's website. The device maker must by law list all the doctors it compensates.

Copyright 2011 ABC News Radio

ABC News Radio