Congressional Letter Urges FDA to Improve Med Tech Pathway

11/08/2011

A bipartisan, bicameral letter was sent to FDA Commissioner Margaret Hamburg recently urging her to improve the agency’s handling of medical technologies. “Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system,” stated the letter.

The signers are asking FDA to:

• Recognize and correct the disparity between “FDA time” versus real time when tracking device approvals;

• Consider potential benefits of harmonization with international testing standards;

• Address the unintended consequences of the conflict of interest rules for advisory panels; and,

• Create a transparent tracking and review system for applications and clearance decisions.

A hearing will be held in the U.S. Senate next week taking a closer look at efforts FDA is working on to improve the regulatory environment,  and examining the impact that today’s challenges are having on patient care and innovation.

http://www.medicaldevices.org/node/1118

~ QD Syringe Systems

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Congressional Letter Urges FDA to Improve Med Tech Pathway