As expected, the third and final (for now, at least) congressional hearing focused on the FDA’s regulation of mobile medical apps was the only one that provided new information for those already well-versed in mobile health. While the past two days of testimonies likely helped members of Congress better understand the concerns of those working or lobbying for the healthcare and technology industries, those testimonies did not reveal anything new about what was actually going on at the FDA.
This morning the FDA’s Christy Foreman, who serves as the Director of the Office of Device Evaluation at the Center for Devices and Radiological Health, shared a number of insights about mobile medical app regulation that before today had not been revealed. Here are five things we learned from the FDA’s testimony during the congressional hearing today:
1. Number of FDA regulated medical apps: The FDA has reviewed approximately 100 mobile medical apps through its regulatory process. (MobiHealthNews pegged it at about 80 in our recent FDA report.)
2. Time it takes for apps to get through 510(k): The FDA estimates that the time it takes for a mobile medical app to get through its 510(k) process is significantly shorter than the average time for most medical devices. Foreman said it takes about 67 days for mobile medical apps.
3. Number of medical apps seeking clearance each year: Foreman also noted that the FDA only reviews about 20 mobile medical apps each year through its medical device regulatory process. Foreman said that means mobile medical apps make up just 0.5 percent of the total medical devices it reviews each year.
4. No Class III mobile medical apps yet: All of the apps cleared by the FDA to date have been considered either Class I or Class II medical devices, Foreman said. The FDA has not found any mobile medical apps to be Class III medical devices yet.
5. When will the final guidance on mobile medical apps be published? Foreman sort of, kind of committed to a deadline for when the final guidance on mobile medical app regulation will be published, but it wasn’t an outright promise. (Considering this hearing was done under oath, it might be understandable that Foreman didn’t want to fully commit.) Foreman said that the FDA had prioritized final guidance for publication this year and that it should be coming out in the coming months. When prompted Foreman said she meant by the end of this fiscal year, which ends on the last day of September for the FDA, but she repeatedly said that it “should” be published by then. The FDA has made hedged predictions about the final guidance being published in the past, but these hearings may serve as a catalyst this time around.
Since Foreman’s comments about the likelihood of the final guidance document being published by the end of the fiscal year were hedged, be sure to read the full exchange between her and Rep. Michael Burgess (R-TX) transcribed below.
Rep. Burgess: “When can we look for final guidance — the final draft? When will that be released?”
Foreman: “We have prioritized that guidance for publication this year. It should be coming soon with the intent of providing clarity to the…”
Rep. Burgess: “Is your microphone working?”
Foreman: “It is on.”
Rep. Burgess: “OK pull it a little closer then.”
Foreman: “We intend to finalize that guidance this year. It is a priority for the agency. It should be coming out in the final months. And the point of the guidance will be to speak… to clarify the questions received during the comment period and provide additional examples to clarify the agency’s policy.”
Rep. Burgess: “Did you say it would be coming out in the final month of this year?”
Foreman: “No, it will be coming out in the coming months.”
Rep. Burgess: “In the coming months. And when you say ‘this year’ you are talking about the calendar year not the fiscal year?”
Foreman: “It should be out by the end of the fiscal year, yes.”
Rep. Burgess: “OK, the ‘fiscal year’. Well, let’s make a note of that.”
If you’d like to watch the entire hearing from this morning, it is now available on the committee’s website here.