US FDA 510(k) From Concept to Clearance

US FDA 510(k) clearance is among the most important processes a medical device manufacturer can undertake when introducing an innovation to market. The impact of an incomplete or inaccurate submission could cost time, money, and competitive advantage.

US FDA 510(k) From Concept to Clearance: A Guide for Medical Manufacturers helps you navigate the complexities of the submission process, providing actionable insights on:

• • What triggers the need for a 510(k) submission
  • The 6 steps of the 510(k) regulatory pathway
  • Demonstrating substantial equivalence and the role of predicate devices
  • Submission preparation and presentation guidelines
  • …and more!