# In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff - FDA Guidance Document Source: https://www.keypedia.com/guidances/guidance-document/in-vitro-diagnostic-ivd-device-studies-frequently-asked-questions-guidance-for-industry-and-fda-staff/d1b047e5-dc30-4134-b852-9ab7c8e9397b > FDA guidance document: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff. Issue date: June 25, 2010. Get complete insights and analysis. --- ## Details - Title: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff - Communication Type: Guidance Document - Product Type: devices - Office Name: Center for Devices and Radiological Health - Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7 - Issue Date: 2010-06-25 - Last Changed: 2020-02-28 - Docket Number: FDA-2007-D-0076 ## Related Documents - [Cellular Therapy for Cardiac Disease: Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/cellular-therapy-for-cardiac-disease-guidance-for-industry/d0a87a21-c69d-46d1-b795-8481faf21a82) - [Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/content-of-premarket-submissions-for-device-software-functions-guidance-for-industry-and-food-and-drug-administration-staff/0cee2fd2-94a6-466f-b1b8-836fd3c8d30f) - [Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/evaluation-and-reporting-of-age-race-and-ethnicity-specific-data-in-medical-device-clinical-studies-guidance-for-industry-and-food-and-drug-administration-staff/9fb9098f-5c24-4238-a9d8-64a10ae06702)