FDA and Device Makers Reach Deal

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The Food and Drug Administration has reached an agreement with medical device makers that should increase the speed in which they evaluate new devices. The much maligned approval process has long been thought to be slow and unpredictable. For the last decade, the FDA has accepted company payments to supplement it's budget and create a smoother process, totaling $295 million in the last agreement. This new deal raises that budget to $595 million over the next five years, allowing the FDA to hire 200 new scientist.

As part of the agreement, the FDA will work toward more predictable, transparent reviews of medical devices. There would be more preliminary meetings before applications are submitted so a company is well prepared when submitting their device. Device makers and users have complained about the FDA's speed compared to the process in foreign countries for years. We've seen many new devices proposed over the last couple of years, but many of them are still help up in the FDA's process while the devices are being used overseas. This new deal should help avoid many of the normal hangups.

The FDA said in a statement it would send the final details of the agreement to Congress once they are completed. Congress must draft the agreement into law and approve it before Oct. 1 this year.


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