About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach....
The health subcommittee of the House Energy and Commerce committee met this week to question Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, about the medical device user fee amendments (MDUFA).
MDUFA is an agreement between the FDA and industry in which the FDA agrees to do certain things in return for industry groups supporting the agency’s work by paying fees...
The FDA, along with the FCC and ONC has finally released the report to Congress required by the FDA Safety and Innovation Act (FDASIA) of 2012. This FDASIA report, called "Proposed Strategy and Recommendations for a Risk-Based Framework," reiterates previously articulated FDA positions on regulatory discretion and avoiding regulatory redundancy between the FDA, ONC, and FDA. It's based on the...
By Bradley Merrill Thompson
This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to have this discussion, and then I’ll get into the recommendations that the so-called “FDASIA working group” made with regard to how to improve FDA regulation.
Current...
There are now more than 100 mobile medical apps registered with or cleared by the FDA as medical devices, according to MobiHealthNews' just-updated report, aptly named: The 103 FDA Regulated Mobile Medical Apps.
When we first published our extensive round-up of FDA regulated mobile medical apps in December 2012, we found 75 apps in FDA's databases. This time around we added those that received...
Rep. Joseph Pitts (R-PA)
This week the US House of Representatives' Energy and Commerce Committee's subcommittee on Health held a hearing to discuss the "Federal Regulation of Mobile Medical Apps and Other Health Software", which ended up being a partial re-run of the committee's FDA-apps hearings back in March. This time around, however, the committee stacked the witness table with supporters...
By Bradley Merrill Thompson
In response to my prior post on this topic, athenahealth's VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions.
As I said in my original...
By Dan Haley, VP of Government Affairs, athenahealth
In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile...
In the next few days -- after two years of waiting -- the FDA will publish its final guidelines for mobile medical apps. That was the plan, anyway.
News of the imminent publication of the guidelines prompted the Bipartisan Policy Center to make moves to put pressure on HHS to stop it. Last week the group got 129 companies and associations to sign a letter that urges the administration to hold off...
The Department of Health and Human Services has formed a new workgroup, charged with "identifying key considerations to improve patient safety and promote innovation in health information technology (Health IT), including mobile medical applications." The group has been selected by HHS and the FCC and will report to the Health IT Policy Committee which advises the ONC.
This is the same workgroup...
