In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 25, 2010
February 28, 2020
d1b047e5-dc30-4134-b852-9ab7c8e9397b
Related Documents
Cellular Therapy for Cardiac Disease: Guidance for Industry
Guidance DocumentOctober 1, 2010Center for Biologics Evaluation and Research
Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentJune 14, 2023Center for Devices and Radiological Health
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 12, 2017Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.