Update on 510(k) Changes: Timeline for Implementation and Assessment of Effects on Industry
FDA continues to review the current guidelines for 510(k) submissions and propose recommendations for changes to this regulatory pathway in order to ensure safety and effectiveness of all new medical products coming to market. In turn, medical device companies are anxious to know what these final changes will be and how they will affect the current process for clearance and approval of a new oe existing product. This session will address upcoming changes to the 510(k) regulatory pathway and will focus on two major points of interest for regulatory affairs executives. The first of which is clarification on the guidance document regarding the criteria for when to submit a 510(k) for a change to an existing product and the measures for evaluatin substantial equivalence in pre-market notifications.