FDA amends guidelines on expedited device review process

06/3/2013 | Clinica (subscription required)

The FDA has revised the guidelines governing its process for granting priority status to medical devices submitted for pre-market approval. The updated guidance reflects changes called forth in the latest iteration of the medical device user fee agreement, including substituting the term "expedited" for "priority." The FDA says that while priority status means a device submission will be considered before others without that status, it does not guarantee it will be approved before other applications.

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