Dear All
The US Food and Drug Administration (FDA) has published a new guidance document titled Guidance for Industry and FDA Staff Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007. This guidance document provides details including who should register with FDA and how to do it, how to list medical devices with FDA, who needs to pay user fees and how payments can be made, and how to make the applicable registrations electronically. This useful FDA guidance document can be downloaded from here.
Regards
S. Subramaniam
The US Food and Drug Administration (FDA) has published a new guidance document titled Guidance for Industry and FDA Staff Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007. This guidance document provides details including who should register with FDA and how to do it, how to list medical devices with FDA, who needs to pay user fees and how payments can be made, and how to make the applicable registrations electronically. This useful FDA guidance document can be downloaded from here.
Regards
S. Subramaniam
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