Hi Anon,
I would say that it depends. My experience with multiple IDE submissions over the past several years has been that FDA tends to be pretty conservative with biocompatibility expectations for long term contact devices in IDEs--even for EFS applications.
In general, my expectation is you would need either biological testing to address the longer term biological endpoints (especially sub-chronic/chronic systemic toxicity), or extractables testing with toxicological risk assessment.
Just a note on terminology: leachables testing is rarely done for implants, as it would strictly speaking require collection of biological specimens and use of analytical methods developed for such complex matrices. Some labs will recommend what they may call leachables studies (really simulated use extractables) as a way to better estimate patient exposure. In my opinion (and experience), such studies have limited utility.
Extractables testing is a challenging and rapidly evolving area of device assessment. In addition to having led the rewrite of ISO 10993-18, I and MED Institute have helped multiple clients through this process. Contact me directly if you would like to discuss in more depth.
Hope that's helpful!
Best regards,
Ted
--
Theodore (Ted) Heise, PHD, RAC
Vice President Regulatory and Clinical Services
MED Institute Inc.
1330 Win Hentschel Blvd.
West Lafayette, IN 47906-4149 USA
765.463.1633 ext. 4444
http://medinstitute.com
theise@medinstitute.com