Regulatory Affairs

What Are the Government Restrictions for your Device

Regulatory Body Resources:

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MAUDE Database

Manufacturer and User Facility Device Experience database comprising reports of device related malfunctions, deaths, and injury.

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Device Recall Search

From the FDA, this database contains medical device recalls since 2002.

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Product Classification

FDA guidance on medical device classification.

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510K Database

Pre-market Notification search database from the FDA.

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PMA Database

Pre-market Approval database from the FDA for class III medical devices.

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FDA Guidance Documents

FDA guidance documents covering the FDAs current stance on a variety of topics.

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Institutional Review Board

Georgia Tech IRB and contact persons.

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Citi Training

Research training for human subjects

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Clinical Studies

Registered ongoing and completed clinical trials