U.S. Congress has passed the Food and Drug Administration Safety and Innovation Act (S. 3187), which is intended to improve the efficiency and predictability of the U.S. Food and Drug Administration’s (FDA’s) review process. It remains now only for President Obama to sign and approve the legislation so it can be implemented.

Industry executives are pleased with the result of what has been a long road for this bill:

"This bill provides for the opportunity to accelerate the introduction of innovative medical devices without compromise to patient safety," said Hank Kucheman, CEO at Boston Scientific. "We are hopeful that these reforms will have a strong and lasting impact on the FDA's ability to address lengthening review times, spur innovation and promote faster patient access to new therapies. We appreciate the collective effort undertaken by Chairman Harkin, Senator Enzi, Chairman Upton and Congressman Waxman to speed this important bipartisan bill through Congress. We look forward to working with the FDA on the implementation of the bill."

Housed within the legislation is the Medical Device User Fee Act (MDUFA), effectively a renewal of the Medical Device User Fee and Modernization Act (MDUFMA), originally passed in 2002 and then reauthorized in 2007.

MDUFMA had four main objectives:

• User fees for medical device premarket approval (PMA) applications, which would provide additional funds to the FDA intended to speed up review processes;
• Performance goals and commitments for many types of PMAs, giving the FDA a roadmap of sorts to follow;
• Inspections of medical device facilities may be conducted by accredited third-party persons under certain circumstances in strictly prescribed conditions; and
• And the FDA has strengthened authority over reprocessed and single-use devices, to make sure the devices are safe and effective.

One of the main objectives of MDUFA is speeding up the FDA review process via increased user fees, which med tech companies are more than willing to pay if it means faster device approval or clearance times. Some of MDUFA’s new provisions include:

• The FDA will be able to monitor high-risk devices that are already on the market, and spur innovation by speeding up review processes for low to medium-risk devices;
• The FDA will be able to reclassify a device on administrative order rather than a more burdensome rule-making process; and
• The FDA will be required to publish a proposed regulation for unique device identifiers by the end of 2012, finalize those regulations by the fall of 2013, and implement a program within two years of the final rule’s publication date.

S. 3187 also includes new provisions and rules for the pharmaceutical industry, including directives for the FDA to inspect foreign drug facilities that produce drugs for use in the Unites States.

S. 3187 passed in the House on Tuesday June 26 2012 by a vote of 92-4. Throughout its journey, the medtech industry has been praising the act as a rare example of bipartisanship on Capitol Hill.

“This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency,” said Stephen J. Ubl, Advanced Medical Technology Association (AdvaMed) president and CEO. “That means more American patients will have access to safe and effective treatments and diagnostics sooner, which is the shared goal of both FDA and industry.”

AdvaMed Chairman and Zimmer CEO David Dvorak had a warning for the industry:

“The legislation … is only the beginning. It will require consistent and effective implementation by FDA, which will be held accountable to meeting all of its commitments.”

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