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FDA Moves Toward Tighter Medical Device Oversight

The Food and Drug Administration has sometimes been a bit lax on regulation of medical devices, partly due to policy decisions and partly due to a lack of manpower at the agency. That situation may change soon, according to an Associated Press article. Here are excerpts:

Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.

The Food and Drug Administration released recommendations Monday night designed to improve oversight of the U.S. device industry, including the government’s ability to recall products that prove unsafe or ineffective.

The FDA’s report comes nearly a year after FDA’s medical devices division endured a storm of criticism from public health advocates and lawmakers.

Last August, the head of the device division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. Last year began with congressional investigators saying the FDA should take immediate steps to make sure more devices are reviewed through the most stringent process.

The recommendations come from two internal FDA panels that were tapped to draft changes in the wake of the outside criticism. The FDA is not bound by the reports, and will accept public comments for 90 days.

“Taken together, these preliminary reports show a smarter FDA, an agency that recognizes both sides of our mission to protect and promote public health,” said FDA devices chief Dr. Jeffrey Shuren.

At the center of the overhaul is the nearly 35-year-old system the FDA uses to grant speedy approval to devices that are deemed similar to products already on the market.

The so-called 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. Tongue depressors, wheel chairs and arm slings are among the devices cleared under the system

About 4,000 devices are cleared every year under the 510(k) system, while about 50 devices are approved under the more stringent system.

But FDA critics say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny.

The FDA’s panel recommends the agency clarify when a device is sufficiently similar to those already on the market to receive 510(k) clearance. The group also recommends that manufacturers be required to submit a summary of all available safety information about their device, instead of just the basic information required under current regulations.

FDA officials said Monday they would likely pursue another recommendations that would make it easier to recall devices on the market that appear unsafe or ineffective.

FDA officials said some of the changes to its approval system could be made in coming months, but more sweeping changes could require new legislation from Congress.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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