While we discussed three of the four challenges/best practices for incorporating antimicrobials onto the surfaces of medical devices in our last post, we left the last and perhaps most complex topic for its own blog. This is the wild world of regulatory approval.
In 2007, the FDA released draft guidance for 510(k) submissions for antimicrobial devices. While no formal guidelines exist, this is the best resource available about what the FDA is looking for – and med-device executives, their regulatory teams and their antimicrobial partners should know it back and forth.
In Lise Moloney’s informational paper, “A Guide to Leveraging Antimicrobials to Protect the Surfaces of Medical Devices,” she counsels readers on what the FDA is looking for in a 510(k) submission, including:
- Indications for use
- Predicate device comparison
- Antimicrobial chemistry
- Mechanism of action
- Release mechanism and kinetics
- Antimicrobial concentration
- Kinetics, toxicity, metabolites and degradation
You can access Lise’s paper to read more about these submission guidelines here.
Leveraging antimicrobials to reduce microbial accumulation on the surfaces of medical devices has been proven to work; yet adding antimicrobial features is still a complex area filled with many “unknowns.” As the call for antimicrobial functionality continues to strengthen, it is imperative that med-device companies embrace this change the right way – defining requirements, understanding manufacturing capabilities, finding the right antimicrobial supplier and preparing for the 510(k) submission – in order to be successful.