January 3, 2013

Jan

FDA Sanofi Aventis recall of Mobile App

January 3, 2013Alan KusinitzNews

This is one of the first mobile medical app recallsl we have seen posted. It is for an app that was only intended to be released in Brazil but was published on the iPhone store and available in the U.S. Its intended use is diabetes education. The full recall excerpt is available on our Recalls...

Jan

FDA Revised PMA Filing Acceptance Guidance

January 3, 2013Alan KusinitzNews

/Docs/FDA-PMAFilingAcceptanceGuidance123112.pdf

Jan

FDA Revised 510(k) Refuse to Accept Policy

January 3, 2013Alan KusinitzNews

/Docs/FDARefuse2AcceptPolicy4510ks123112.pdf

Jan

FDA Final eCopy Guidance

January 3, 2013Alan KusinitzNews

/Docs/FDAeCopyFinalGuidance123112.pdf

Jan

FDA eCopies eSubmitter Quick Reference Guide

January 3, 2013Alan KusinitzNews

http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdf

FDA Sanofi Aventis recall of Mobile App

FDA Revised PMA Filing Acceptance Guidance

FDA Revised 510(k) Refuse to Accept Policy

FDA Final eCopy Guidance

FDA eCopies eSubmitter Quick Reference Guide

Upcoming Public Courses

Corporate Office

Day

FDA Sanofi Aventis recall of Mobile App

FDA Revised PMA Filing Acceptance Guidance

FDA Revised 510(k) Refuse to Accept Policy

FDA Final eCopy Guidance

FDA eCopies eSubmitter Quick Reference Guide

Upcoming Public Courses

Corporate Office