FDA’s Device Changes Defer Biggest Issues

* Ruling delayed on new data requirements for some devices
* Other steps aim to streamline process
* Medtronic CEO describes FDA plan as “more balanced”
* Industry group: drops or defers access-denying proposals
* Health equipment index down in line with broader market (Adds FDA, analyst comments, share prices)

U.S. health officials unveiled steps to streamline reviews of medical devices and deferred decisions on contentious issues the industry feared would slow approval of new products.

The FDA said on Wednesday it would ask the Institute of Medicine for input on seven proposals, including creation of a new category of devices that would require more data to win approval. A report from the IOM is expected this summer.

The delay on the toughest issues was a win for the device industry, which worried the FDA would impose standards that would slow development of new products reviewed under an abbreviated process known as 510(K).

“This is a more balanced approach that sends a positive signal to industry that the FDA is engaged, listening and concerned,” Medtronic Chief Executive Bill Hawkins told Reuters.

The shorter approval pathway requires companies to show a product is “substantially equivalent” to one already on the market and typically does not require testing in people. The process has drawn fire from critics who say it is too widely used and allows unsafe products to reach the market. Most medical devices – about 3,000 each year – are cleared through that program. […]

One consumer advocate said the FDA had moved away from more dramatic changes that would have helped patients in response to industry lobbying.

“FDA has backed down on important safety measures that would have saved lives,” said Diana Zuckerman, president of the National Research Center for Women & Families. […]

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