Regulatory Educational Materials from CDRH

The FDA’s Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) is providing resources with the most current and accurate information about medical devices and radiation-emitting electronic products.

Device Advice

CDRH recently updated web pages in Device Advice, including:

• CDRH Proposed Guidances for Fiscal Year 2022 (FY2022)
• De Novo Classification Request
• How to Enroll in eMDR Program
• Premarket Submissions: Selecting and Preparing the Correct Submission
• Voluntary eStar Program

CDRH Learn

CDRH has launched a new playlist on the FDA YouTube Channel. The playlist consists of the 7 most popular, foundational CDRH Learn modules. For anyone seeking the basics about medical device and radiological health regulations – this is a great place to start!

• CDRH Learn Video Playlist: Medical Device Education Basics 101 (YouTube)

View CDRH Learn Modules

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 products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered.

Recent Webinar Recordings

• Content of Premarket Submissions for Device Software Functions: Draft Guidance
• De Novo Final Rule: Overview and Guidance Updates
• Over-the-Counter (OTC) Hearing Aids Proposed Rule and Personal Sound Amplification Products (PSAPs): Draft Guidance

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

Upcoming Webinars

• Transition Plans for COVID-19 Related Medical Devices: Draft Guidances on February 22, 2022
• Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Final Guidance on March 1, 2022
• Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Final Guidance on March 22, 2022

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

CDRH holds a bi-weekly virtual town hall series to help answer technical questions about the development and validation of tests for SARS-CoV-2 on COVID-19 test development and validation. Please join us for town halls on:

• February 23, 2022, from 12:15 PM - 1:15 PM ET

Recordings and transcripts of all COVID-19 Test Development and Validation Town Halls are available on the FDA.gov website.

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Questions?

If you have questions, contact the Division of Industry and Consumer Education.