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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  3. Device Advice: Comprehensive Regulatory Assistance
  4. Postmarket Requirements (Devices)
  5. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
  6. eMDR – Electronic Medical Device Reporting
  7. eMDR System Status
  1. eMDR – Electronic Medical Device Reporting

eMDR System Status

The production and pre-production eMDR systems experience weekly downtime for maintenance and other scheduled activities. The Electronic Submissions Gateway (ESG) also experiences downtime for these activities, even when eMDR is operating normally. Maintenance (whether scheduled or unscheduled) should take place over the weekend. For this reason, reporters are asked to submit their reports between the hours of 10:00am Monday and 5:00pm Friday (New York timezone, GMT -5). 

Scheduled Maintenance

The chart below lists all scheduled maintenance activities for the CDRH data center. Downtime may occur on weekends not listed below due to unscheduled maintenance or ESG downtime.

eMDR System Status 2024

Start Date/Time

End Date/Time

Environment

Fri January 5, 2024 
21:00    
Sun January 7, 2024 
23:59
Production
Tue January 16, 2024 
04:00
Fri January 19, 2024 
23:59
Test
Fri January 26, 2024 
21:00
Sun January 28, 2024 
23:59
Production
Mon February 19, 2024 
04:00
Fri February 23, 2024 
23:59
Test
Fri March 01, 2024 
21:00
Sun March 03, 2024 
23:59
Production
Mon March 18, 2024 
04:00
Fri March 22, 2024 
23:59
Test
Fri March 29, 2024 
21:00
Sun March 31, 2024 
23:59
Production
Mon April 15, 2024 
04:00
Fri April 19, 2024 
23:59
Test
Fri April 26, 2024 
21:00
Sun April 28, 2024 
23:59
Production
Mon May 20, 2024 
04:00    
Fri May 24, 2024 
23:59
Test
Fri May 31, 2024 
21:00
Sun June 02, 2024 
23:59
Production
Mon June 17, 2024 
04:00
Fri June 21, 2024 
23:59
Test
Fri June 28, 2024 
21:00
Sun June 30, 2024 
23:59
Production
Mon July 15, 2024 
04:00    
Fri July 19, 2024 
23:59
Test
Fri July 26, 2024 
21:00    
Sun July 28, 2024 
23:59
Production  
Mon August 19, 2024 
04:00    
Fri August 23, 2024 
23:59
Test
Fri August 30, 2024 
21:00
Sun September 1, 2024 
23:59
Production  
Mon September 16, 2024 
04:00
Fri September 20, 2024 
23:59
Test
Fri October 04, 2024 
21:00    
Sun October 06, 2024 
23:59
Production
Mon October 14, 2024
04:00
Fri October 18, 2024  23:59 Test
Fri October 25, 2024 
21:00  
Sun October 27, 2024 
23:59
Production
Mon November 18, 2024 
04:00
Fri November 22, 2024 
23:59    
Test
Fri December 06, 2024 
21:00
Sun December 08, 2024 
23:59
Production
Mon December 16, 2024 
04:00
Fri December 20, 2024 
23:59
Test
Fri January 10, 2025 
21:00    
Sun January 12, 2025 
23:59
Production
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