FDA's proposed 'globally harmonized' PMA alternative

This draft guidance document for industry and FDA staff describes the Food and Drug Administration's proposed program to evaluate a globally harmonized alternative for premarket procedures. The program is intended to assess the feasibility of an internationally harmonized format and content for premarket submissions, e.g., premarket notification (510(k))submissions and premarket approval (PMA) applications. The following is a link to the complete set of documents.