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FDA issues draft PMA (Pre-Market Approval) Clinical Study Guidance

bio_subbu

bio_subbu

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Dear All

The US Food and Drug Administration (FDA) has issued guidance document on “Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff Design Considerations for Pivotal Clinical Investigations for Medical Devices” on 15th August 2011 to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.

To access the aforesaid guidance document please refer here.

Regards

S. Subramaniam
 
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