chemical characterization / molecular weight chemical stabilizers / given product / e.g. solution / material/device / degradation products / device manufacturer / marketed device / /
MedicalCondition
Acute inflammation / particular infection / allergy / immune granuloma formation / local injury / immune system dysfunction / chronic inflammation / tissue and organ injury / autoimmune disease / neoplastic disease / frequent and serious infections / hypersensitivity / Inflammation / /
MedicalTreatment
immunosuppression / immunostimulation / /
Organization
U.S. Department of Health And Human Services / Life Sciences Office / Center for Devices and Radiological Health / office of Device Evaluation / Food and Drug Administration Center for Devices / FDA / Radiological Health Molecular Biology Branch Division / /
GUIDANCE FOR INDUSTRY AND FDA REVIEWERS Immunotoxicity Testing Guidance Document issued on: May 6, 1999