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FDA Bill Puts Laser Devices on Fast Track

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Terrence K. O'Brien

WASHINGTON -- Legislation that would help new laser medical devices reach the marketplace faster was overwhelmingly approved by the US Senate this fall. The bill, which also addresses federal approval of new drugs, is still pending in Congress.
The bill to streamline the US Food and Drug Administration's balky review process marks the first significant reform of the agency in 30 years, its backers say. Among other things, it would give seriously ill people easier access to experimental treatments and allow the use of private, third-party experts to speed up reviews of new medical devices.
Although some consumer groups warned that safety was being sacrificed for speed, industry representatives said the change was long overdue.
Medical devices have been regulated under rules developed more than 20 years ago, according to the Health Industry Manufacturers Association (HIMA), an industry lobbying group. While the FDA approval process has improved in recent years, the legislation will make it easier for new lifesaving technology to reach the market sooner, said Jim Benson, vice president of the group.
A critical change affecting the photonics industry is a self-certification process that should save time in the FDA approval process.
"When a [company] meets an ISO standard, they can certify that they meet that standard. The company doesn't have to send data in to the FDA," Benson said.
Laser technology companies note that it now can easily take four years for a new laser-equipped product to enter the US market. In most European countries, the review time usually takes less than a year.
The cost of bringing a laser medical instrument in the US from idea to market can be anywhere from $1 million to $20 million, according to HIMA. That drove many domestic companies overseas to market their products before offering them at home.
Benson noted that it is uncertain when the effects of the new rules will be felt in the marketplace..

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Nov 1997
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