IOM Calls For Overhaul of Device Regulation

Merrill Goozner

First posted 7/29/11 on Gooz News

The Institute of Medicine committee that’s been reviewing medical device regulation for the past two years called this morning for a sweeping overhaul of Food and Drug Administration rules that allow some implanted devices to enter the market without adequate safety and effectiveness testing. The process — known as 510(k) — provides for minimal testing of devices if they are deemed “substantially equivalent” to a device that is already on the market.

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Reminders of Art Buchwald

PAUL LEVY

Originally published on [Not] Running A Hospital

I cannot locate the article, but I think it was Art Buchwald who once wrote a humorous piece about competition between the two airlines who ran shuttle services between New York and Washington, DC. It went something like this:

The piece opens with a phone call to the US Airways agent. “I see you just raised your fares to New York.”

“Yes, we did that to compete against Pan Am. They just raised their fares.”

“Wait, I thought the idea of competition was to lower prices.”

“Why would we do that? If we lowered our fares, and they followed suit, it would be a race to the bottom. We would both lose money.”

Recently, Tufts Health Plan (730,000 members) and Harvard Pilgrim Health Care (1 million members) announced a plan to merge here in Massachusetts. This would leave two major insurers in the state, along with Blue Cross Blue Shield (3 million members).

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