FDA Clearance Remediation
When a 510(k) submission hits unexpected roadblocks, we step in. Borderless MedDev helps medical device companies communicate with the FDA, plan acceptable responses, and get back on track.
What We Do
510(k) Remediation
Post Market Issues: Complaints and Recalls
Q-Sub Planning
Additional Information Letter (AINN) Responses
Compile Results and Problem Resolutions
From Questions to Confidence
The path to market looks different for everyone.
When NSE or AINN responses catch you off guard, Borderless MedDev will equip you with a plan and tailor a strategy to your specific needs. Our team works directly with regulators to clarify requirements, respond to feedback, and make sure your submission stays on track.
510(k) Submissions and Remediation Support
Even with careful preparation, 510(k) applications do not always go as planned. You might receive unexpected feedback, requests for additional data, or confusing guidance that can stall your progress. If you don’t have regulatory experience, it’s easy to feel overwhelmed and uncertain about the way forward.
That’s where we come in.
Borderless MedDev specializes in helping innovators navigate these challenges with clarity and confidence. Whether you're preparing for 510(k) or remediating a stalled submission, we will guide you from start to finish.
Services Include:
Strategic planning for FDA submissions
Support for Pre-Submission meetings and Q-Sub packages
Authoring and compiling 510(k) and De Novo submissions
Managing additional information (AINN) requests
510(k) Remediation for delayed or denied applications
Direct communication with FDA reviewers to resolve issues
Guidance for post-market regulatory compliance