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Medtronic's VP for Global Affairs argues for FDA inspection changes on Capitol Hill: 5 key notes Featured

Written by  Laura Dyrda | Wednesday, 03 May 2017 09:26
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Medtronic's Vice President for Global Affairs Pat Shrader visited Congress earlier this week to discuss the FDA plant inspection process and request changes, according to a Star Tribune report.

Here are five things to know:

 

1. Ms. Shrader spoke to a House subcommittee about the inspection process, saying the inspections were too "erratic" for companies to provide the appropriate information, clarification and follow-up.

 

2. Speaking on behalf of AdvaMed as well as Medtronic, Ms. Shrader said the FDA provided too short of notice for companies to gather and present required documents.

 

3. During her presentation, Ms. Shrader asked Congress to standardize inspections of device manufacturers and move to a risk-based system for scheduling inspections.

 

4. Patient advocacy groups present disagreed, stating the importance of inspecting facilities with high-risk implantable devices and the ability of companies to hide compliance issues if they have too much advance warning.

 

5. The legislation being considered would continue to provide the FDA authority to inspect medical device facilities.

 

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