August 2024

Welcome to the Summer 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:

• Total Product Life Cycle Advisory Program (TAP) (08/12/2024)
• Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions (08/07/2024)
• eSTAR Program (06/24/2024)
• About Manufacturer and User Facility Device Experience (MAUDE) Database (06/06/2024)

REdI 2024

Thank you to the thousands of people who joined us for the FDA Regulatory Education for Industry (REdI) 2024 Annual Conference.  If you missed the live program, view the recordings:

• Plenary Session: Innovation in Medical Product Development
• (segment starts at 47:00 of video)
• Part 1 (May 29)
• Part 2 (May 30)

Medical Device User Fees

The Medical Device User Fee Amendments (MDUFA) User Fees for Fiscal Year 2024 have published and are in effect from October 01, 2024 through September 30, 2025.  Additional Information:

• Federal Register: Medical Device User Fee Rates for Fiscal Year 2024
• Device Advice: Medical Device User Fees
• Device Advice: Reduced Medical Device User Fees: Small Business Determination (SBD) Program

CDRH Webinars

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

• Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A (08/07/2024)
• In Vitro Diagnostics Product (IVD): Classification (07/16/2024)
• Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method (07/10/2024)
• Medical Device Sterilization Town Hall: Sterilization Open Q&A (06/12/2024)
• Enforcement Policies for Certain In Vitro Diagnostics – Draft Guidances (06/05/2024)
• Medical Device Sterilization Town Hall: Sterilization Method Selection for New and Existing Devices (05/23/2024)

DICE’s newsletters are also available online.