Regulatory Focus™ > News Articles > Hamburg: Device Approvals Process Set to Become Less Burdensome

Hamburg: Device Approvals Process Set to Become Less Burdensome

Posted 23 August 2012 | By Alexander Gaffney, RAC 

The head of the US Food and Drug Administration (FDA) thinks the approval process for medical devices is about to become considerably smoother thanks to the passage of the Medical Device User Fee Amendments (MDUFA), reports the Minneapolis Star Tribune.

Hamburg was attending an August 2012 meeting with Sens. Al Franken (D-MN) and Amy Klobuchar (D-MN) and representatives from the medical device industry regarding the pace at which FDA regulators are approving medical devices. The agency has come under frequent criticism from the industry for what companies see as an unnecessarily slow approval process compared to that of the EU.

For Hamburg, however, the recent passage of the FDA Safety and Innovation Act-and with it, the MDUFA provisions-will ease passage for many devices as FDA is able to boost its regulatory capacity by hiring new staff, upgrading its systems and training its staff more frequently.

"We're starting to see change already," said Hamburg, according to The Tribune.

"This part of the world is terribly important to what's going on in medical innovation, particularly in the medical device area," Hamburg added. "This is sort of a critical moment, with the passage of the legislation."

Breathing Room for Hamburg

Hamburg may have other reasons to feel optimistic about the future of approvals. A recent study published in the New England Journal of Medicine (NEJM) shows that US medical device approvals are actually faster than the approvals process in the EU when reimbursement decisions are also taken into account.

The study, "Patient Access to Medical Devices-A Comparison of US and European Review Processes," also noted the US generally had more consistent review times for reimbursement decisions.

"Using this information, we determined that the time it takes to bring innovative, high-risk devices to patients in the United States is similar to or shorter than that in the top four European markets," wrote Saptarshi Basu and John Hassenplug, the authors of the study. They noted previous assessments were unfair in that they did not compare "equivalent standards in terms of… the end points of the process and the key end point of market access."

By bundling in more of the review process into the initial regulatory review, in other words, the US is simply shifting its review resources toward the front end of the process rather than the back end. With additional review resources put into place by MDUFA, FDA may soon be able to reduce its review times even further, said Hamburg.

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