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MDUFA Passage Means Push for Changes to Device Policy


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.

The law 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.

There are more than 40,000 medical apps available to download to portable devices, but which ones are going to need FDA approval?

Currently, the FDA has proposed policing only those apps that use supplemental attachments to transform a mobile platform into a medical device and others that act as accessories to an already regulated medical device. But that could change.

Get answers to your toughest questions in just a day — no travel required — with FDAnews’ Medical Device Mobile Apps What Needs FDA Approval. Register today.