U.S. Representative Joe Pitts, chairman of the House Energy and Commerce health subcommittee, said the U.S. is falling behind in the global competition to create innovative medical devices because of the FDA's approval process in an editorial in the Philadelphia Enquirer.
"Medical devices have to go through a rigorous approval process. For good reason, companies are required to submit their devices to scientific tests to determine safety and effectiveness," he wrote. "But in recent years, the FDA's approval process has become a bottleneck. It has become less transparent, less predictable and less efficient. Some companies have waited years for approval, spending millions on testing only to have the rules change."
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"Medical devices have to go through a rigorous approval process. For good reason, companies are required to submit their devices to scientific tests to determine safety and effectiveness," he wrote. "But in recent years, the FDA's approval process has become a bottleneck. It has become less transparent, less predictable and less efficient. Some companies have waited years for approval, spending millions on testing only to have the rules change."
Related Articles on Medical Device Approval:
Legislators Petition FDA for Faster, Simpler Medical Device Review Process
FDA Issues Two Draft Guidances on Medical Device Development, Studies
John Stossel: The FDA is Killing Us