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Moody's: Enhanced FDA Scrutiny Could Pressure Device Makers

money.cnn.com

Heightened Food and Drug Administration surveillance for problems with products already on the market could pressure medical-device makers by boosting research-and-development costs and the risk of negative news, according to Moody's Investors Service.

Manufacturers of high-tech devices such as drug-coated stents - which are made by Boston Scientific Corp. (BSX), Johnson & Johnson (JNJ), Medtronic Inc. (MDT) and Abbott Laboratories (ABT) - appear to be most vulnerable to the increased scrutiny, Moody's said in a report issued Thursday.

The credit ratings firm examined the impact of an FDA plan announced in May, called "Sentinel", that aims to comb health databases from a variety of sources to identify product issues more quickly.

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