By Stewart Eisenhart, Emergo Group
Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Services Department.
A new HHS study examined 36 instances of scientific disagreements occurring at the FDA’s Center for Devices and Radiological Health (CDRH) between 2008 and 2010, finding that in many instances more training of CDRH staff and supervisors on procedures for resolving disagreements was necessary, and that staff were also unclear about accountability for documentation required for the CDRH’s resolution process.
The CDRH had already issued an updated system for dealing with scientific disagreements during medical device reviews in 2009, but HHS investigators found that not all medical device review personnel were aware of those changes.
In order to reduce future instances in which scientific disputes regarding medical device reviews potentially delay or derail a device’s path to market in the US, the HHS report issues three recommendations:
- CDRH should clearly define requirements for documenting and resolving scientific disagreements.
- All CDRH reviewers and managers must be trained on new policies and procedures for resolving scientific disagreements.
- Accountability must be more clearly assigned for contents of documents and files of all submissions.
Of the 36 medical device submissions causing internal CDRH disagreements, 19 involved 510(k) submissions; 11 were premarket application submissions, five were Investigational Device Exemption applications, and 11 were Humanitarian use device exemptions. In terms of device type, radiological products were most likely to cause scientific disagreements by far.
The FDA has concurred with the HHS recommendations, which will hopefully result in more efficient resolutions of device review-related disagreements in the future.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.