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FDA Considers Medical Device Overhaul

System for clearing devices popular with manufacturers because it offers a cheap, fast pathway to market; critics say the process has been used to hastily approve high-risk implants.

WASHINGTON (AP) -- Makers of medical devices could be the latest companies 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.

The FDA is holding an all-day meeting Thursday to examine its 35-year-old system for clearing devices that are similar to products already on the market.

The process is popular with manufacturers because it offers a cheap, fast pathway to market.

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

Analysts say a revamped approval process could mean more time and money for manufacturers.

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