FDA Will Deploy eMDR Updates on March 17

The FDA’s latest updates to its Electronic Medical Device Reporting (eMDR) system will go live on March 17, making five changes to the online system devicemakers and importers must use to submit MDRs.

The changes this year are:

• The patient’s age must be formatted in the required units;
• Reports must include the product code;
• The implant date must precede the explant date;
• Adverse event problem codes must be included; and
• A contact email address must be included. 

Effective March 17, the system will not accept reports that do not conform to these changes, the agency said.