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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) provides resources with the most current and accurate information about medical devices and radiation-emitting electronic products.

Join Us for the FDA Regulatory Education for Industry (REdI) 2022 Annual Conference!

You’re invited to attend the FDA Regulatory Education for Industry (REdI) 2022 Annual Conference on June 6-10, 2022, featuring regulatory tracks for drugs, devices and biologics. Conference is free! Please register to attend.

Device Advice

CDRH recently posted these program updates in Device Advice:

• Breakthrough Devices Program (04/15/2022)
• Voluntary eSTAR Program (03/11/2022)
• Quality System (QS) Regulation/Medical Device Good Manufacturing Practices (02/22/2022)
• Proposed Rule: Quality System Regulation Amendments – Frequently Asked Questions (02/22/2022)

CDRH Reorganization

CDRH’s Office of Product Evaluation and Quality recently announced organizational changes including the creation of a new office and new divisions. These updates are reflected on various CDRH web resources:

• CDRH Management Directory by Organization
• Office of Product Evaluation and Quality
• OCEA: Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality
• OHT7: Office of In Vitro Diagnostics, Office of Product Evaluation and Quality
• OHT8: Office of Radiological Health
• ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality
• CDRH Learn: How is CDRH Structured?

Webinars and Virtual Town Hall Series for COVID-19 Test Development and Validation

CDRH’s Medical Device Webinar Program hosts webinars to educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting electronic products. These forums provide an opportunity for the public to interact with the FDA to have their questions answered:

Recent Webinars

• Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, Final Guidance (03/22/2022)
• Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, Final Guidance (03/01/2022)
• Transition Plans for COVID-19 Related Medical Devices, Draft Guidances (02/22/2022)

In addition to these recordings, slides and transcripts are available for each webinar.

Upcoming Webinar

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Draft Guidance on June 14, 2022, from 1:00 – 2:15 PM ET

Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation

CDRH holds a bi-weekly virtual town hall series to answer technical questions about the development and validation of tests for SARS-CoV-2. Please join us for upcoming town halls:

• Town Hall #86 – June 1, 2022, from 12:05 – 1:00 PM ET
• Town Hall #87 – June 15, 2022, from 12:05 – 1:00 PM ET
• Town Hall #88 – June 29, 2022, from 12:05 – 1:00 PM ET