FDA draft guidance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 One draft guidance is the long-awaited guidance on clinical (as well as patient) decision support, while the other deals with changes to medical software policy based on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 October 17, 2016
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on establishing clinical evaluation guidelines for SaMD, but is written by an international organization of device regulators, the International Medical Device Regulators Forum, of which FDA is a member. The...
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 June 9, 2016
In 2012 The Wall Street Journal published a story that quoted a big medical device company spokesperson explaining that they couldn't provide patients the medical device data gathered by implanted devices inside their own bodies because regulators wouldn't allow it. "Medtronic says federal rules prohibit giving Ms. Hubbard's data to anyone but her doctor and hospital. 'Our customers are...
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FDA's Bakul Patel Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms,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 Jonah Comstock June 18, 2014
The FDA has, at long last, released draft guidance for how pharmaceutical companies should behave on limited-character social media platforms like Twitter and when correcting misinformation on third-party sites. The FDA carefully controls labeling, advertisement, and promotion for drugs and devices requiring FDA clearance. It makes sure that companies never list the benefits of a drug without...
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 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 Neil Versel September 19, 2013
Departing national health IT coordinator Dr. Farzad Mostashari would prefer that the Food and Drug Administration unilaterally issue a long-anticipated final guidance on mobile medical apps rather than waiting for inter-agency consensus with the Federal Communications Commission and Mostashari's own Office of the National Coordinator for Health Information Technology. "I testified before Congress...
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...