The FDA July 12 and 13 will hold a public workshop and meeting on "The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers."
FDA
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
FDA Grants PMA for QView Medical’s Automated Breast Ultrasound System
The device is meant for breast screening in asymptomatic dense breasted women whose mammograms returned negative.
Sandoz Announces Voluntary Recall of Potentially Contaminated Losartan
The affected product was distributed after October 8, according to the FDA.
