IMDRF

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 One draft guidance is the long-awaited guidance on clinical (as well as patient) decision support, while the other deals with changes to medical software policy based on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 November 28, 2016
Since its well-publicized meeting with the FDA in 2013, Apple has continued to meet with the agency regularly as well as to correspond by phone and email, according to emails obtained by Babyforyou.net.ua via a Freedom of Information Act request to the FDA.   These emails show that Apple and the FDA have discussed the App Store review process, the 510(k) process, ResearchKit apps, diagnostic apps,...
By MHN Staff April 15, 2013
By Bradley Merrill Thompson, EpsteinBeckerGreen I’ve always found the saying, “Be careful what you wish for; you might just get it” to be rather condescending. In a way it suggests that we are too stupid to manage our own affairs. But like any popular saying, it probably has a kernel of truth. Frankly, I’m a little nervous about a request made by industry for international medical device...

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