FDA Details Time Clock Strategies for PMAs, 510(k)s in Draft Guidance

The FDA last week released updated guidance describing how it intends to comply with submission review timelines set during user fee negotiations earlier this year.

The documents — on PMAs and 510(k)s — revise guidances from 2008 and 2004, respectively, to explain how the agency will use the actual-time “review clock” schedule established in the FDA Safety & Innovation Act, as well as how actions submitters take might affect the timeline. The four-year spans correspond to the original Medical Device User Fee Authorization Act (MDUFA) and its two reauthorizations.

This summer’s MDUFA III was the first to set some goals in total calendar days, as opposed to “FDA days” that don’t include time the agency spends waiting for responses from devicemakers.

MDUFA III sets a goal for the FDA to have “substantial interaction,” such as a meeting, with PMA filers within 90 FDA days of receipt of 65 percent of applications in 2013. That goal increases to 95 percent by 2017. The total time to decision goal is 395 days for 90 percent of PMAs in 2013, rising to 95 percent in 385 days by 2017.

And that may not be the only upcoming review change for devices.

A California congressman recently announced plans to introduce a bill requiring the FDA to establish an Office of Mobile Health to help speed the development and approval of device apps.

The mobile app market is booming, and devicemakers are often the first to get something out. Is that app technically considered a medical device that would be regulated by the FDA … do you know?

Don’t second guess yourself, be sure to attend FDAnews’ rebroadcast of Medical Device Mobile Apps: What Needs FDA Approval.

Attendees will come away with ideas on how to transform their traditional devices into apps, a better understanding of what needs FDA approval and lessons learned from a firm that already has an FDA-approved app on the market. Register for this Wednesday webinar rebroadcast today.