FDA final guidance

By Jonah Comstock December 7, 2017
FDA Commissioner Scott Gottlieb dropped three new FDA guidance documents today, two draft guidances and a final guidance. One draft guidance is the long-awaited guidance on clinical (as well as patient) decision support, while the other deals with changes to medical software policy based on Congressional mandates in the 21st Century Cures Act. The final guidance is on Software as a Medical Device...
By Jonah Comstock August 9, 2016
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices. Lack of regulatory clarity is often cited as a force hampering innovation in digital health, so these moves by the FDA toward greater clarity are likely to be welcomed in many parts of the industry....
By Brian Dolan February 9, 2015
FDA's Bakul Patel Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status. Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where...
By Brian Dolan February 13, 2014
While the most recent meeting made headlines, the first time Apple executives actually met with the FDA wasn't at the end of 2013, but rather three-and-a-half years ago. The Financial Times pointed this out earlier this month. On June 11, 2010 Apple's Vice President of Software Technology Bud Tribble and the company's VP of Worldwide Government Affairs Cathy Novelli met with the FDA's Director of...
By Brian Dolan November 26, 2013
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...
By Brian Dolan November 21, 2013
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 Aditi Pai October 3, 2013
The FDA final guidance finally published last week and it included very few surprises. One new section in the final guidelines -- that was not included in the draft guidance -- is a list of the types of apps that the FDA says will fall under its enforcement discretion. That means that these apps may meet the definition of a medical device, but the "FDA intends to exercise enforcement discretion...
By Jonah Comstock September 27, 2013
There are 229 dermatology-focused medical apps in the Apple, Android, Blackberry, Nokia Windows app stores, according to a study recently published in the Journal of the American Medical Association Dermatology. More than half of the apps are patient-facing (51 percent), with 41 percent targeted at health care providers and 8 percent aimed at both groups. The authors excluded certain apps form...
By Brian Dolan September 23, 2013
PillPhone: One of the first patient-facing mobile apps to get FDA clearance. Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn't. After more than two years since the FDA first published its draft guidance on how it regulates...
By MHN Staff September 4, 2013
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...