MDUFA III Signed Into Law; Clock Ticking on Enacting Changes

July 27, 2012

President Barack Obama signed the FDA Safety and Innovation Act, S. 3187, into law July 9, reauthorizing the Medical Device User Fee Act (MDUFA) and Prescription Drug User Fee Act, and creating new user fee programs for generic drugs and biosimilars.

While new fee structures and review commitments don’t go into effect until Oct. 1, Obama’s signature has set off a number of clocks and deadlines for the FDA and HHS to begin enacting other provisions.

For example, the FDA now has until May 2013 to issue final regulations establishing a unique device identifier (UDI) system. MDUFA instructs the agency to finalize its UDI scheme no later than six months after the close of comments on proposed regulations and gives the FDA until Dec. 31 to get its proposal out. However, the agency published the draft regulations just days after they were approved by the Office of Management and Budget, where they had been stalled for the past 12 months.

Regulators must immediately withdraw a June 2011 guidance on 510(k) device modifications and not issue any new guidance until finalizing a report to Congress. Until that time, the FDA’s 1997 guidance will apply.

The law also gives the FDA two years to publish social media guidance and instructs HHS to issue a report to Congress on an appropriate regulatory framework for health IT software, including mobile medical apps.

Among other time-sensitive changes, the FDA has a year to develop a strategy for advancing regulatory science.

You’ve probably read the headline that this new legislation will more than double the FDA’s user fees collected from device manufacturers to review new medical device applications. But the act does much more than that; it provides major changes to the way the agency regulates devicemakers — touching on everything from approvals to inspections.

Get all the details of this law with FDAnews’ MDUFA 2012 First-Hand Knowledge for Medical Device Companies.

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