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CDRH Regulatory Educational Materials

The Division of Industry and Consumer Education (DICE) at the U.S Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has developed resources to provide you with informative updates about medical devices and radiation-emitting electronic products.

FDA Regulatory Education for Industry (REdI) 2023 Annual Conference

We invite you to attend the FDA Regulatory Education for Industry (REdI) 2023 Annual Conference on June 5-9, 2023, featuring regulatory tracks for drugs, devices and biologics. The conference is free! Please register to attend.

Device Advice

Recently Posted Program Updates

• Total Product Life Cycle Advisory Program (TAP) (03/02/2023)
• Breakthrough Devices Program (03/28/2023)
• Exporting Medical Devices (03/29/2023)

Use eSTAR for Your Submissions

The eSTAR Program helps you prepare regulatory submissions to CDRH. Starting October 1, 2023, eSTAR submissions will be mandatory for all 510(k)s, unless exempted. Begin your planning now.

• FDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions

Use the CDRH Portal to Submit and Track Your Submission

Use the CDRH Customer Collaboration Portal (“CDRH Portal”) to send your medical device eSTAR or eCopy premarket submission. You can monitor its progress at any time.

• Create an online account

CDRH Learn

CDRH recently posted the following educational modules:

• COVID-19 EUA Transition Policy for Devices, Final Guidances Webinar
• COVID-19 IVD Town Hall on EUA Transition Policy Final Guidances
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Contact DICE

Learn more about educational resources for you. If you have questions about DICE, please Contact Us – Division of Industry and Consumer Education (DICE).