510(K) CLEARANCE CASE STUDY
CHALLENGE:
The manufacturer of a new laser-resistant endotracheal tube device needed to use an older predicate for their 510(k) submission to the FDA. While still commercially available, the predicate device was over 20 years old at the time of submission, with limited regulatory information and test data available. FDA often imposes closer scrutiny on submissions that use older predicates, so a collaborative approach between AlvaMed’s team and the manufacturer were essential.
During review, the FDA asked for a substantial amount of information on comparison testing. AlvaMed and the manufacturer’s team needed to correctly and clearly respond to agency reviewers’ questions. The review window was closing rapidly, and the team required prompt turnaround of responses to the agency.
APPROACH:
AlvaMed’s team of regulatory specialists was assigned to the project. Side-by-side comparison testing of the company’s tube against the predicate tube was essential to the demonstration of substantial equivalence. The initial test data reports supplied by the client were deemed insufficient during review. The FDA also requested additional information on device materials and pyrogenicity.
The team responded to the request for additional information through interactive review with the agency. However, the FDA was still concerned about some of the testing as it related to the predicate, and suggested that the submission should be withdrawn if new testing could not be performed before the review deadline. With only 3 weeks left on the review clock, AlvaMed’s team proposed adding a warning statement to the device labeling as a solution.
RESULTS:
The labeling update was accepted and the device was cleared. The submission was difficult due to the FDA’s test data expectations and the limited time remaining in the review window. The labeling update suggested by the team at AlvaMed successfully brought the client through the review process to market clearance.
During the project AlvaMed provided the following regulatory support:
- Regulatory strategy
- Predicate research and selection
- Research and writing of 510(k)
- 510(k) eCopy submission
- Meeting guidance and coordination between the FDA and manufacturer
- Resolved secondary questions from the FDA
- Labeling approach successfully resolved primary reviewer questions
