Medical device change control can be as critical to your company as when you first launched your product. Prudent manufacturers can meet all requirements without an excessive drain on resources. The key remains in proper situational and risk analysis.
Three Types Of Medical Device Change Control
Changes to medical devices can have huge repercussions or no substantial effect at all. For example, color change usually will not influence a device’s safety, efficacy, or performance. Other changes profoundly affect these parameters. Lastly, in some cases it’s not so clear. Nevertheless, every modification must be documented, and, if need be, reported to the FDA.
Letter-To-File Medical Device Change Control
Letter-to-file level changes typically are cosmetic or represent improvements without creating an entirely new product. If no impact has been made on safety, efficacy, or performance a letter-to-file can be drafted and archived in-house. If for any reason, the FDA inquires about the change, the documentation can be produced quickly.
Even for minor modifications, it pays to include subject matter experts’ written analyses about the change. Make sure the letter specifically addresses issues of safety and performance.
510(k)/PMA Medical Device Change Control
In these instances, an FDA reportable change to the device has occurred. It might be that the device has been adapted for a new indication, or that performance has been altered. For example, revised mechanics of a product might require physician re-training.
After making your analysis, if you’ve determined that a significant change has occurred, or if you’re not sure, then it’s probably wise to go ahead and file a 510(k)or Premarket Approval (PMA) supplement.
Mitigate Medical Device Change Control Risk
Every device change that creates opportunity also creates risk. In each case, proper documentation with qualified analysis is critical. Any modification should be backed up with a report that clearly identifies the what, when, and why a change was made.
Beyond simple regulatory justification, answering these questions also satisfies your internal processes and resource management. Ideally, these issues should be thoroughly addressed before any design change or testing even begins.
Medical Device Change Control Subject Matter Experts
Subject matter experts can be a valuable resource in the medical device change control process. For example, prior consultation might uncover pitfalls, or enhancements, that can alter – or abort – the change process completely. Advanced validation can save you from wasting resources on a change that ends up being counterproductive.
Third party-medical consultation also provides the necessary support for any change documentation in the eyes of the FDA. This remains the case for both letter-to-file and 510(k)/PMA processes. Consultants can also suggest which level of reporting is appropriate.
If you decide a letter-to-file is adequate, make it as complete as possible. That way it becomes easy to re-package it into a formal FDA acceptable document at a moment’s notice.