FDA plans to implement a new program, known as “Pre-Sub”, in which they will provide feedback on studies to medical device companies before they apply for marketing approval. The program is similar to an already existing process for drug companies, called a Special Protocol Assessment. “Pre-Sub” is thought to be an aid in facilitating the development of premarket submission and in helping the industry avoid regulatory hurdles during the review process.
FDA is also asking for comments to the Pre-Sub draft guidance. Comments are due by October 13, 2012. For more information, click here.
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