GMP Tips - New Guidance Document - June 20, 2006

On June 15, FDA issued an update to the Inspection of Medical Device Manufacturers guidance document.

The compliance program outlined in this guidance document encompasses five regulations for inspecting medical device firms, including CFR21 - Part 820, the Quality System Regulation for Medical Devices. Under the Quality System regulation, manufacturers are expected to control their devices from design stage through post-market surveillance. The Master Device Reprting, Tracking, and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed. This compliance program provides specific guidance for each of these regulations.

Read a copy of this new guidance document at
www.gmptrainingsystems.com/asp/resources.asp
Click on Medical Devices.

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