SEQUESTRATION AND DEVICE APPROVALS (Orthopedics This Week)
Avoiding “The Sequester” is Washington’s new pork.
Medical device companies are going to pay about $100 million in Food and Drug Administration (FDA) user fees in 2013 to help cover the costs of being regulated. However, due to sequestration, the FDA can’t touch $85 million of that. That means a slowdown in device reviews, clearances and approvals.
Legislation was introduced in both the House and the Senate recently to shield what the FDA gathers directly from industry. The bill was assigned to a congressional committee on July 31, 201...
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