CDRH: My technology is...

I am working on an in vitro diagnostic - where can I get started?

FDA webpage giving IVD overview

Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions – July 2010

CLIA Waiver resources

CDRH Learn module “In Vitro Diagnostics” CLIA Waiver Applications Draft Guidances from 1/9/2019

Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices – January 2008

Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Draft Guidance for Industry and Food and Drug Administration Staff –November 2018

Recommendations for Dual 510(k) and CLIA Waiver by Application Studies Draft Guidance for Industry and Food and Drug Administration Staff –November 2018

I am working on a surgical and/or therapeutic device - where can I get started?

FDA webpage giving surgery devices overview

Computer-Assisted Surgical Systems

I am working on an imaging device - where can I get started?

FDA webpage giving medical imaging overview

Laws and Regulations (Radiation-Emitting Products)

I am working on a digital health technology - where can I get started?

FDA webpage giving digital health overview

CDRH Learn module “IT and Software” Digital Health from 2/24/2015

FDA webpage with list of guidances related to digital health

I am working on a companion diagnostic device where - can I get started?

FDA webpage giving companion diagnostics overview

CDRH webinar “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product” from 8/18/2016

In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff – August 2014

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product Draft Guidance for Industry and Food and Drug Administration Staff – July 2016

I am working on a drug/device combination product - where can I get started?

FDA contacts for combination products

FDA webpage on Request for Designation (RFD) process to assign jurisdiction to for combination products

FDA webpage with list of guidances related to combination products

Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff – February 2019

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development Draft Guidance for Industry and FDA Staff –February 2016