CDRH DICE Quarterly Newsletter

If your email program has trouble displaying this email, view as a webpage. 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) has developed the resources below to provide you with the most current and accurate information about medical devices and radiation-emitting products. Join Us for the FDA Regulatory Education for Industry (REdI) 2021 Annual Conference! You're invited to attend the FDA Regulatory Education for Industry (REdI) 2021 Annual Conference July 19-23, 2021, featuring regulatory education tracks for drugs, devices and biologics.  The conference is free, but you must register to attend. Register Here Attending this event may be approved for up to 30.25 continuing education units. Device Advice CDRH recently posted these program updates in Device Advice: Accreditation Scheme for Conformity Assessment (ASCA) (06/25/2021) ASCA-Accredited Testing Laboratories (06/23/2021) 510(k) Program Pilots (05/27/2021) Early Feasibility Studies (EFS) Program (05/19/2021) ASCA-Recognized Accreditation Bodies (04/21/2021) Training, Guidance, and Other Resources for Third Party Review Organizations (04/08/2021) CDRH Learn CDRH recently posted the following educational modules: How to Study and Market Your Device section (under "Standards") Module 4: How to Use Consensus Standards in Premarket Submissions Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions Postmarket Activities section (under "Inspections – Global Harmonization") MDSAP: Management Process MDSAP: Device Marketing Authorization and Facility Registration MDSAP: Measurement, Analysis and Improvement Process MDSAP: Medical Device Adverse Events and Advisory Notices Reporting Process MDSAP: Design and Development Process MDSAP: Production and Service Controls Process, Part 1 MDSAP: Production and Service Controls Process, Part 2 MDSAP: Production and Service Controls Process: Part 3 View CDRH Learn List of Modules Watch CDRH Industry Basics on the Standards Program If you missed the live broadcast of the CDRH Industry Basics Program about the Use of Consensus Standards and the ASCA Pilot, view the recording.

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