Get the Latest Regulatory Educational Materials from CDRH

The Division of Industry and Consumer Education (DICE) at the FDA’s Center for Devices and Radiological Health (CDRH) recently developed or updated the resources below to provide you the latest and most accurate educational information about medical devices and radiation-emitting electronic products.

Device Advice

CDRH recently posted these pages in Device Advice:

Framework for the Safety and Performance Based Pathway (01/22/2019)
FAQs about Investigational Device Exemption, Foreign companies/studies, Acceptance of Data from Clinical Investigations (02/21/2019)
Premarket Approval Application, Data Requirements, Acceptance of Data from Clinical Investigations (02/21/2019)
Getting a Humanitarian Use Device to Market, HDE Content, Acceptance of Data from Clinical Investigations (02/21/2019)
Evaluation of Automatic Class III Designation (De Novo), How to Prepare a De Novo Request, Acceptance of Data from Clinical Investigations (02/21/2019)

CDRH Learn

CDRH recently released the following educational modules in these categories:

Start Here/The Basics

Postmarket Activities

Exporting Medical Devices (03/26/2019)

View CDRH Learn List of Modules

Medical Device Webinars and Stakeholder Calls

CDRH also hosts regulatory webinars and stakeholder calls for the medical device industry.View past recordings and upcoming listings.

Industry Workshops and Conferences

We are looking forward to seeing everyone who registered to attend the Regulatory Education for Industry (REdI) Annual Conference on May 29 -30, 2019!

If you missed out on this event, don’t worry. We host the REdI conference every year, as well as other workshops and webinars on the FDA’s drug and medical device regulatory requirements. Keep an eye out for information on all upcoming activities on our next quarterly newsletter!