The United States Food and Drug Administration (FDA) has issued its medical/dental device educational newsletter, which can be read below.

November 2024

Welcome to the Fall edition of DICE’s Educational Newsletter.  Stay up to date on the latest regulatory resources on a variety of FDA medical device and radiological health programs.

Device Advice 

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

• IDE Application (10/22/2024)
• Device Registration and Listing (10/07/2024)
• Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files (08/26/2024)
• eMDR System Enhancements (08/11/2024)

CDRH Learn

CDRH Learn consists of multi-media videos, presentations and modules.  CDRH recently posted these new modules:

Start Here/The Basics! | MDUFA Small Business Program

• How to Complete Form FDA 3602: MDUFA Small Business Qualification and Certification for a Business Headquartered in the United States (11/04/2024)
• How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States (11/04/2024)

Postmarket Activities | Quality Management System Regulation

• Overview of Quality Management System Regulation (08/30/2024)
• Navigating the Quality Management System Regulation (08/30/2024)

Postmarket Activities | Medical Device Recalls

• Introduction to Medical Device Recalls (10/04/2024)

CDRH Webinars

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

• Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A (10/30/2024)
• FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs) (10/24/2024)
• Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle (10/15/2024)
• Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A (10/09/2024)
• The Voluntary Improvement Program: How to Enroll, Opportunities, and Best Practices (10/08/2024)
• Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b) (09/24/2024)
• Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket Submissions (09/11/2024)
• Final Guidance: Remanufacturing of Medical Devices (09/10/2024)
• Draft Guidance: Predetermined Change Control Plans for Medical Devices (09/03/2024)
• In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements (08/22/2024)

Resources for You - Consumers

This page provides regulatory information of special interest to specific audiences and stakeholders:

• Consumers (Medical Devices) (10/29/2024)

Contact Us

We value your feedback.  DICE answers questions from the medical device industry and consumers of medical devices and radiation-emitting electronic products.  If you have questions about medical devices or radiation-emitting products, please e-mail us at: DICE@fda.hhs.gov.  Visit our pages on FDA.gov to learn more about educational resources for you.  DICE’s newsletters are also available online.