New Article on CDRH Learn

Recommendation

29-31 March 2023
Heidelberg, Germany

The Validation Manager in the Pharmaceutical Industry

You could already read in the past about the FDA CDRH's (Center for Devices and Radiological Health) website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date.

The Division of Industry and Consumer Education (DICE) at the FDA is responsible for this website. In addition to CDRH Learn, there is also a "Device Advise" section. The following contributions have been added to this section in the last few months (with the respective publication dates in brackets in the format month/day/year):

• Breakthrough Devices Program (08/03/2022) 
• Accreditation Scheme for Conformity Assessment (ASCA) (06/07/2022)  
• ASCA-Accredited Testing Laboratories (09/01/2022) 
• Testing Laboratories: How to Participate in the ASCA Pilot (06/28/2022) 
• Accreditation Bodies: How to Participate in the ASCA Pilot (06/07/2022) 
• 510(k) Third Party Review Program (08/19/2022)  
• Review Memos for Third Party 510(k) Reviewers (08/19/2022) 
• eMDR System Enhancements (08/30/2022)  
• Coding Resources for Medical Device Reports (08/22/2022) 
• Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) File (08/22/2022)

The CDRH Learn has also been updated. New is a nearly 18 minute video on "How to Get Your Electronic Product on the U.S. Brand".

For more information please see the DICE overview website.