FDA considers changes to decades-old medical devices approval system

Ahead of the Bell: FDA meets on medical devices

WASHINGTON — Makers of medical devices could be the latest sector to see their industry overhauled by a safety-conscious Food and Drug Administration.

The agency spent much of the last decade overhauling its pharmaceutical safety system, following recalls of several best-selling drugs.

Now the FDA is holding an all-day meeting Thursday to examine its nearly 35-year-old system for clearing devices that are 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.

About 3,500 devices are cleared every year under the 510(k) system.

Critics charge that the process has been used to hastily approve high-risk implants that deserve closer scrutiny.

The FDA has formed an internal panel to review and improve the medical device approval process. But with no major controversy to drive reform — as Vioxx did with drug safety in the last decade — it could be years before any major changes are put in place.

The FDA has asked the Institute of Medicine to look at the issue, and their report is due by March 2011.

While the ultimate shape of reform is still unclear, Wall Street expects any changes to take a toll on company balance sheets.

Companies could be asked to submit more data to win approval — requiring more research and development spending.