Per the notice below, the United States Food and Drug Administration (FDA) has issued its latest regulatory educational materials.

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.

Join Us for the FDA Regulatory Education for Industry (REdI) 2024 Annual Conference!

We invite you to attend the FDA Regulatory Education for Industry (REdI) 2024 Annual Conference on May 29-30, featuring regulatory tracks for drugs, devices and biologics.  The conference is free!  Please register to attend in person or online.

Device Advice

Device Advice explains medical device laws, regulations, guidances, and policies across the total product life cycle.  CDRH recently posted these program updates:

• ASCA-Accredited Testing Laboratories (05/13/2024)
• Remanufacturing and Servicing Medical Devices (05/09/2024)
• Total Product Life Cycle Advisory Program (05/07/2024)
• Accreditation Scheme for Conformity Assessment (ASCA) (04/30/2024)
• About Manufacturer and User Facility Device Experience (MAUDE) Database (04/23/2024)
• eSTAR Program (03/29/2024)

CDRH Webinars

CDRH recently held these webinars on recent guidances, regulations, and various policies:

• Final Rule: Medical Devices; Laboratory Developed Tests (05/14/2024)
• Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (04/30/2024)

This year, CDRH launched a new town hall series on medical device sterilization and held these recent events:

• Topics and Formats for the Continuing Sterilization Series (04/29/2024)
• The Value and Use of Recognized Consensus Standards in Premarket Submissions (03/21/2024)

Learn more about educational resources for you.  If you have questions about medical devices or radiation-emitting products, please contact the Division of Industry and Consumer Education (DICE).