Case Study: Navigating Regulatory Challenges to Achieve FDA Clearance
Background and Challenge: A medical device manufacturer sought FDA clearance for its innovative lidocaine delivery device designed to deliver aerosolized lidocaine to the upper airway to facilitate office-based procedures. The company initially engaged with a different consulting company to prepare and submit the 510(k) application. However, after receiving an Additional Information Needed (AIN) letter from […]
