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 the FDA, the company sought a second opinion from AlvaMed to address the extensive requests and navigate the complex regulatory process.
The AINN letter included 108 deficiencies, with significant requests including:
- Justification for the chosen predicate device.
- Biocompatibility testing, including gas pathway testing per ISO 18562.
- Electrical safety and usability testing (IEC 62366).
- Comprehensive hazard analysis and performance testing.
The FDA granted a 360-day response window, including an additional 180-day extension due to COVID-19-related delays. Despite AlvaMed’s and the company’s efforts to compile and submit a thorough response, the FDA withdrew the submission due to incomplete gas pathway testing caused by an HPLC equipment failure. AlvaMed was then contracted to resubmit the device.
Approach:
AlvaMed took over the project and implemented a strategic approach to address the challenges:
- Comprehensive Review of Initial Withdrawn 510(k): Conducted a detailed review of all prior documentation, reports, and the initial AINN response to identify gaps and areas where regulatory risk could be addressed and reduced.
- Updated Testing and Documentation: Ensured all testing, including ISO 18562, was completed and aligned with the updated standards. Updated documents considered “at risk” and incorporated the complete prior AINN response into the new submission.
- eSTAR Template Transition: Reformatted the submission to comply with the FDA’s new eSTAR template requirements, ensuring all data was presented clearly and comprehensively.
- FDA Engagement: Utilized a 10-day meeting to clarify FDA requests and maintained open communication with the agency throughout the review process. Simplified responses into straightforward tables and agreed to last-minute FDA changes to facilitate the review process.
Results:
After a rigorous 1,163-day process involving six FDA submissions and meetings, the device received FDA clearance in October 2024. Key achievements included:
- Successful resolution of FDA concerns regarding predicate device selection, biocompatibility, and usability.
- Compared to the initial submission (prior to engaging with AlvaMed) which received 108 questions, the second re-submission received 4 AINN requests.
- Efficient handling of AINN requests, including the updated ISO 18562 testing and hazard analysis.
- Streamlined communication and collaboration with the FDA, ensuring a smooth review process despite initial setbacks.
Impact:
AlvaMed’s regulatory expertise and strategic approach enabled the company to overcome significant challenges and achieve FDA clearance. The successful outcome allowed this innovative office-based lidocaine delivery device to enter the U.S. market, enhancing patient care and expanding its business opportunities.
Key Takeaways:
- Expert Guidance Matters: Partnering with experienced regulatory consultants can help navigate complex FDA requirements and address challenges effectively.
- Adaptability is Critical: Transitioning to new submission formats (e.g., eSTAR) and adapting to updated standards are essential for successful FDA clearance.
- Proactive Communication: Engaging FDA reviewers early and maintaining transparent communication can streamline the review process and resolve issues efficiently.
- Comprehensive Preparation: Thoroughly addressing all FDA requests and ensuring complete documentation are key to avoiding delays and achieving timely clearance.
This case study underscores the importance of regulatory expertise, strategic planning, and collaboration in achieving successful FDA clearance for innovative medical devices.
