PBL is offering support to biocompatibility clients through assistance with test and method selection for biocompatibility testing. As regulatory bodies, such as the FDA, push for more complex testing, it because even more necessary to correctly categorize a device and choose the most appropriate test methods.
In addition, PBL can support report review of prior testing conducted according to outdated standards. We can determine where testing may be deficient, and where additional biocompatibility studies may be necessary for FDA submission.
With over 30 years of experience performing biocompatibility testing, PBL has performed testing used in the submission of hundreds of device applications.
Contact PBL to learn more, or to discuss your specific biocompatibility project.
Information on FDA Biocompatibility Guidance: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf